Engage With Us Techsol Life Sciences’ Pharmacovigilance team is delighted to participate in the World Drug Safety Congress Europe, a premier global platform that unites experts in drug safety, regulatory science, and technology. Our participation highlights our unwavering commitment to advancing patient safety through regulatory expertise, operational excellence, and innovative safety solutions. This event offers a valuable opportunity for us to connect with industry leaders, explore cutting-edge advancements in pharmacovigilance—including AI and automation—and exchange insights on navigating today’s complex regulatory landscape. Through our presence, we continue to strengthen our position as a trusted partner in end-to-end pharmacovigilance services, supporting pharmaceutical, biotech, and medical device companies in delivering safe and effective therapies worldwide.   Schedule a Meeting With Us Submit

Life Cycle Management Change control and regulatory impact assessments Our regulatory experts collaborate closely with cross-functional teams to ensure changes are implemented efficiently with no disruption to market authorization or supply continuity. Request a Consultation Change control and regulatory impact assessments At Techsol, we offer strategic support for change control and regulatory impact assessments, helping pharmaceutical and biotech companies manage internal changes while ensuring global regulatory compliance. Whether the change involves manufacturing, packaging, labeling, testing, or supply chain activities, we provide a risk-based evaluation of the regulatory impact and guide the appropriate submission strategy.  Our Services Include: Regulatory Impact Assessment Categorization of Change Control and Classification Cross-Functional Coordination Preparation of Justification Documents Submission Strategy and Planning Post-Implementation Compliance Tracking Our Expertise and Value Proposition End-to-End Regulatory Insight: We understand the full lifecycle impact of changes and ensure your regulatory decisions are aligned with business needs and HA expectations Global Experience: Our team handles change assessments and submissions across major markets, ensuring alignment with local and international regulatory frameworks Risk-Based Approach: We apply ICH Q9 principles and agency guidelines to assess change impact, ensuring a defensible and efficient regulatory strategy Lifecycle Compliance Management: Techsol helps you maintain product integrity and compliance from development through commercialization even as your operations evolve Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Life Cycle Management Electronic Regulatory Dossiers Our regulatory operations team specializes in dossier planning, compilation, publishing, and version control to facilitate seamless submissions across global regulatory agencies including the FDA, EMA, MHRA, Health Canada, and others. Request a Consultation Management of Electronic Regulatory Dossiers (eCTD / NeeS Formats) Techsol offers end-to-end support for the creation, submission, and lifecycle management of electronic regulatory dossiers in compliance with eCTD (Electronic Common Technical Document) and NeeS (Non-eCTD electronic Submission) standards. We ensure your product dossiers remain compliant, submission-ready, and aligned with Health Authority expectations throughout the lifecycle of the product. Our Services Include: Initial dossier setup in eCTD or NeeS format Lifecycle maintenance, including updates for variations, supplements, renewals, and responses to authority queries Gap analysis and conversion of legacy dossiers from paper or NeeS to eCTD format Validation and quality checks using industry-standard publishing tools Submission planning and tracking, ensuring timely delivery and acknowledgment by Health Authorities Metadata management, folder structure alignment, and document granularity support for high-quality submissions Archiving and version control of all submitted dossiers to maintain audit readiness and regulatory transparency Expertise and Value Proposition Global Submission Expertise: We manage region-specific requirements for eCTD/NeeS across the US, EU, Canada, APAC, and other major markets Regulatory Publishing Excellence: Our team uses validated industry tools and follows strict quality control protocols to deliver error-free, HA-compliant submissions Efficient Lifecycle Updates: Techsol supports dossier maintenance for a wide range of submission types, including post-approval changes, safety updates, and labeling variations Digital Compliance and Readiness: We keep your regulatory dossiers current, organized, and aligned with Health Authority expectations—reducing risk and ensuring faster approvals Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Life Cycle Management Labeling Updates Our Regulatory team will ensure that the all labeling changes whether prompted by new safety data, regulatory requests, or company-driven updates are accurately reflected, scientifically justified, and compliant with regional Health Authority guidelines. Request a Consultation Labeling updates (USPI, SmPC, PIL, CCDS) At Techsol, we understand the critical importance of maintaining accurate and compliant product labeling throughout the product lifecycle. Our regulatory experts provide end-to-end support for the preparation, review, and submission of labeling updates to meet evolving regulatory requirements across global markets. We manage a wide range of labeling documents, including: USPI (United States Prescribing Information) SmPC (Summary of Product Characteristics) for the EU PIL (Patient Information Leaflet) CCDS (Company Core Data Sheet) for global consistency Our Services Include: Labelling Development and Updates Preparation and revision of core labelling documents including: US Package Inserts (USPI) Summary of Product Characteristics (SmPC) Patient Information Leaflets (PIL) Company Core Data Sheets (CCDS) Regulatory Review and Compliance Promotional Material Assessment Lifecycle Management Cross-Functional Collaboration Benefits of Effective Labeling & Promotional Support Ensures full compliance with applicable legal, regulatory, and industry standards Minimizes risk of regulatory penalties, fines, and product recalls by providing accurate, and clear information Prevents misleading, false, or deceptive claims in both labelling and promotional materials Enhances transparency and truthful communication to protect consumer rights and safety Facilitates regulatory inspections, audits, and documentation requirements with consistent product information Supports traceability, accountability, and supply chain integrity through clear labelling and aligned promotional content Promotes ethical marketing practices and adherence to corporate social responsibility guidelines Reduces regulatory scrutiny by aligning promotional claims strictly with approved labelling and product data Builds trust and credibility with regulators, consumers, and stakeholders through compliance and transparency Helps maintain market access and competitive advantage by meeting evolving regulatory demands Our Expertise and Value Proposition Proven Global Regulatory Expertise: Over 500+ labeling submissions delivered, with in-depth knowledge of US FDA, EMA Process Standardization and Best Practices: Well-defined workflows for labeling updates and change submissions minimize delays, regulatory risks, and ensure high-quality deliverables Harmonized Global Labeling Strategy: Support for consistent labeling across global markets while meeting country-specific requirements and maintaining regulatory alignment Agile Response to Regulatory Changes: Rapid integration of safety updates and urgent directives into USPI, SmPC, PIL, and CCDS documents to maintain market readiness End-to-End Lifecycle Support: Comprehensive management from document drafting, version control, and cross-functional coordination to complete regulatory submission support Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Life Cycle Management Renewals and Reassessments Our regulatory professionals ensure that your product remains aligned with the latest scientific evidence and regulatory expectations, enabling long-term market continuity and patient safety. Request a Consultation Renewals and Reassessments MA Renewals are regulatory submissions required to extend the validity of a product’s marketing authorization after its initial approval period (commonly 5 years in the EU and many other regions). After the renewal is granted, the authorization typically becomes indefinite, provided the product continues to meet regulatory requirements. Reassessments are formal regulatory reviews of an already authorized product to ensure its ongoing benefit-risk balance remains positive. These may be routine (e.g., periodic) or triggered by safety signals, new scientific data, or changes in guidelines. Techsol’s offers end-to-end support for Marketing Authorization (MA) Renewals and Reassessments, ensuring full compliance with global regulatory requirements. Our approach to renewals includes the systematic collection and analysis of updated safety, efficacy, and quality data, including critical documentation such as Periodic Safety Update Reports (PSURs) and benefit-risk evaluations. We prepare and maintain the required dossier components particularly Module 1 and updated sections of Modules 2 to 5 and manage timely submissions to Health Authorities to avoid any disruption in market authorization. For reassessments, Techsol provides strategic oversight by identifying regulatory or safety-driven triggers, reviewing cumulative clinical and post-marketing data, and conducting robust benefit-risk assessments. Where applicable, we manage interactions with Health Authorities to support label updates, usage restrictions, or re-evaluation requests. Our regulatory professionals ensure that your product remains aligned with the latest scientific evidence and regulatory expectations, enabling long-term market continuity and patient safety. Our Services Include: Marketing Authorization (MA) Renewals Reassessments and Re-evaluations Data Consolidation and Administrative Updates Submission and HA Engagement Our Expertise and Value proposition Comprehensive Renewal & Reassessment Management: End-to-end support for MA renewals, re-evaluations, and regulatory reassessments across global markets Global Regulatory Expertise: Deep knowledge of FDA, EMA, MHRA, Health Canada, TGA, and other regional requirements to ensure compliance and timely approvals Strategic Submission Planning & Dossier Management: Proactive timeline tracking, Modules 1–5 compilation, and ongoing dossier maintenance to prevent lapses Data Integration & Gap Analysis: Consolidation of safety, efficacy, and quality data with early identification of gaps for corrective actions Benefit-Risk Assessment & Scientific Justification: Robust evaluation aligned with clinical and post-marketing evidence to support regulatory decisions Regulatory Intelligence & HA Engagement: Continuous monitoring of evolving requirements and direct liaison with health authorities to address queries efficiently Technology-Driven Regulatory Operations: Digital tools and regulatory platforms enable efficient tracking, workflow management, and submission readiness Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Life Cycle Management Variations EU Our regulatory experts ensure precise determination of variation type, appropriate documentation, and adherence to procedural requirements, whether changes are administrative, quality-related, or impact the safety or efficacy of the product. Request a Consultation Variations (Type IA, IB, II for EU, CP/MRP/DCP/National) Effective lifecycle management of medicinal products within the EU requires a structured and compliant approach to handling regulatory variations. Changes to the terms of a marketing authorization (MA) are classified by the European Medicines Agency (EMA) and national competent authorities into Type IA, Type IB, and Type II variations, based on the potential impact on product quality, safety, and efficacy. Each variation type is governed by specific regulatory guidelines, defined timelines, and procedural requirements. Regulatory strategies must align with the applicable submission routes Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), or purely National procedures to ensure timely implementation and uninterrupted product availability. At Techsol, we provide end-to-end regulatory support for the classification, preparation, and submission of variations in accordance with the European Union (EU) regulatory framework, enabling Marketing Authorization Holders (MAHs) to maintain ongoing compliance while efficiently managing post-approval product changes. Techsol Expertise Across EU Variation Types We provide regulatory support across all categories of EU variation submissions: Type IA Variations: Minor changes with no significant impact on quality, safety, or efficacy. These are submitted as post-implementation notifications, without requiring prior approval from the competent authority Type IB Variations: Moderate changes that are not classified as Type IA or Type II. These require prior notification and regulatory assessment. Techsol ensures accurate variation scope definition and timely submission to avoid review delays Type II Variations: Major changes that may significantly affect product quality, safety, or efficacy. These require a comprehensive scientific evaluation, and we support dossier preparation, justification development, and authority engagement for favorable outcomes Support Across All EU Regulatory Procedures Techsol manages variation submissions through all applicable EU regulatory pathways: Mutual Recognition Procedure (MRP): For products authorized in one Member State, we coordinate submission to the RMS, manage communication with CMS, and support responses to regulatory questions for recognition across additional Member States. Decentralized Procedure (DCP): For new products seeking parallel approvals in multiple EU Member States, we manage dossier preparation, procedural timelines, and regulatory interactions to ensure a harmonized review and approval process. National Procedure: For country-specific variations, we adapt submission strategies to meet national requirements and maintain close coordination with local health authorities to secure timely approvals. Value Proposition Regulatory Precision: In-depth knowledge of EU regulatory frameworks, variation classification rules, and procedural nuances. Comprehensive Submission Management: From dossier compilation to post-submission follow-up, we ensure seamless execution. Multi-Country Coordination: Expertise in handling MRP/DCP/National procedures and regulatory correspondence across multiple markets. Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Life Cycle ManagementPost-approval supplements US FDA As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly. Request a Consultation Post-Approval Supplements At Techsol, we specialize in providing comprehensive regulatory support for the preparation and submission of Post-Approval Supplements (PAS) to ensure ongoing compliance with FDA requirements. As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly. Our regulatory team manages all supplement types including CBE-0, CBE-30, and Prior Approval Supplements (PAS) supporting changes related to manufacturing processes, formulation, labeling, and packaging. We ensure proper classification of each change, complete and accurate dossier preparation, and timely submission to facilitate FDA review, reduce approval timelines, and maintain uninterrupted product availability. Our Services Includes: Techsol supports all categories of FDA post-approval supplements, with precision and compliance at the core of our services: CBE-0 (Changes Being Effected – Immediate Implementation): Submissions for changes that may be implemented immediately upon FDA receipt. Our team prepares and submits supporting documentation concurrently to meet regulatory expectations. CBE-30 (Changes Being Effected in 30 Days): For moderate changes, Techsol ensures submission of all required data 30 days prior to implementation, enabling clients to proceed with confidence upon FDA clearance. PAS (Prior Approval Supplements): For significant changes requiring FDA review and approval before implementation, our regulatory experts craft robust submission packages to minimize review cycles and mitigate risk of delays. Our Expertise At Techsol, we bring deep regulatory expertise and a proactive approach to managing post-approval changes across global markets. Here’s why leading pharmaceutical companies trust us: End-to-End Support: From strategy development to submission and agency follow-up, we manage the complete lifecycle of post-approval changes Global Regulatory Expertise: Proficient in FDA, EMA, and other major regulatory authorities’ requirements for supplements, variations, and amendments Accurate Change Classification: We perform impact assessments and determine the correct supplement type, reducing the likelihood of FDA rejections or resubmissions Submission Excellence: Our team delivers fully compliant, submission-ready dossiers (eCTD/NeeS), ensuring timely and successful filings Life Cycle Management Services CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Regulatory Capabilities OverviewTOTALRegulatory Services Overview From Molecule to Market – Seamless Regulatory Support at Every Step for Global Biopharmaceutical Enterprises Request a Consultation Simplify End-to-End Pharmacovigilance Operations by combining People, Process, Technology, Automation & Quality TOTALRegulatory is Techsol Life Sciences’ proprietary regulatory business solutions methodology, purpose-built to support biopharmaceutical, vaccine, cell therapy, and gene therapy companies throughout the entire product lifecycle from early development to market authorization and post-approval compliance. Unlike traditional models, TOTALRegulatory delivers a fully integrated, end-to-end regulatory framework that aligns strategy, operations, and technology. Our approach combines deep domain expertise with smart regulatory planning, seamless global submissions, and proactive lifecycle management. A key differentiator lies in our ability to conduct detailed regulatory gap analyses and produce globally compliant, submission-ready documentation that adheres to the highest standards of quality, compliance, and risk mitigation. By leveraging digital tools and process automation, TOTALRegulatory ensures that sponsors are always ahead of evolving regulatory expectations. Key Service Highlights Develop global regulatory strategies (FDA, EMA, EU MDR/IVDR, MHRA, APAC, ROW) to support development and market entry Conduct regulatory due diligence, including gap/risk assessments and support for licensing or acquisitions Analyze competitors and predicate products to guide submission strategy and regulatory positioning Provide lifecycle regulatory support: pre-IND/IDE, IND/IDE, NDA/BLA/ANDA, PMA/510(k), and post-marketing phases Author and compile high-quality CMC dossiers (Modules 2 & 3), DMFs, and CTD/eCTD submissions Manage Health Authority interactions, including submission responses, briefing books, and meeting support Execute complete publishing and submission workflows: planning, compilation, validation, and electronic gateway submission Deliver global labeling compliance services: SPC, USPI, local language labeling, artwork review, and SPL conversions Provide expert regulatory medical writing for clinical/non-clinical sections, CO, NCO, summaries, and PDE reports Key Benefits Frees up internal teams for strategic work – eliminates up to 60% of the manual effort Reduces errors and inefficiencies Ensures compliance with global regulations and best practices Enables centralized oversight and real-time monitoring Seamlessly integrates with your existing systems Salient Features of Service Delivery Comprehensive, end-to-end regulatory lifecycle management and standalone services with customizable engagement models Full-spectrum regulatory services integrated with technology platforms Flexible resource deployment through regulatory professional services, FTE-based insourcing, or hybrid engagement models Direct regulatory liaison support, including strategic communication and response to Health Authority (HA) queries and deficiency letters All service models are powered by real-time regulatory intelligence and AI-driven automation to enhance speed, compliance, and decision-making Fully auditable and compliant with global regulatory standards (FDA, EMA, MHRA, etc.) Centralized project governance ensures consistency, risk mitigation, and transparency 24×7 regulatory operations support with proactive issue management Positioned as a strategic regulatory partner and extended team to enable faster approvals and sustained compliance across markets Content Authoring Services Regulatory Briefing Documents Read More CMC Content Authoring Read More Non-Clinical Content Authoring Read More Clinical Content Authoring Read More Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More Local Labeling & Translations Read More SmPC & ePI Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Life Cycle Management Services Regulatory Life Cycle Management Read More CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit Request a Demo Submit

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Life Cycle Management Biosimilar and Biologic LCM Request a Consultation Overview Biologics are advanced, large-molecule therapies derived from living cells, playing a pivotal role in treating complex conditions such as cancer, autoimmune disorders, and rare diseases. Biosimilars are highly similar alternatives to licensed biologic reference products, developed to match the safety, purity, and efficacy profiles without clinically meaningful differences. From early development to post-marketing surveillance, biologics and biosimilars demand a comprehensive and dynamic regulatory strategy. The biologics regulatory pathway includes key milestones such as Investigational New Drug (IND) submissions, Biologics License Applications (BLA), and continuous lifecycle updates driven by manufacturing changes, safety monitoring, and evolving global regulatory expectations. For biosimilars, regulatory focus is placed on demonstrating analytical and clinical comparability to the reference product, along with a strong emphasis on ongoing pharmacovigilance and risk management. At Techsol, we support end-to-end regulatory product lifecycle management to ensure that both biologics and biosimilars meet stringent global compliance requirements. Our services encompass regulatory submissions, change control management, labeling compliance, and adherence to Good Manufacturing Practices (GMP). Effective lifecycle management not only ensures sustained product quality and patient safety but also enhances market access and long-term commercial success. Management of comparability data and post-approval commitments Biologics and biosimilars are complex therapeutic products derived from living systems, making them highly sensitive to changes in manufacturing processes, sites, equipment, or raw materials. Due to their inherent variability, regulatory agencies require rigorous oversight across the product lifecycle—including the demonstration of comparability and fulfillment of post-approval commitments (PACs). Global regulatory authorities (FDA, EMA, PMDA, Health Canada, and WHO) mandate that sponsors provide robust scientific evidence to confirm that changes do not adversely affect product quality, safety, or efficacy. Comparability data and post-approval activities must be captured, assessed, and reported as part of a proactive lifecycle management (LCM) strategy. Regulatory Requirements and Expectations Techsol helps sponsors navigate complex and evolving expectations tied to lifecycle changes for biologics and biosimilars. We align our strategies with regulatory frameworks such as: ICH Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process FDA Guidance on CMC Post Approval Changes – e.g., Changes to an Approved Biologics License Application (BLA) EMA Variation Regulation (EC) No 1234/2008 and Classification Guidelines Health Canada Post-Notice of Compliance (NOC) Changes Guidance WHO Guidelines on Biotherapeutics and Biosimilars Lifecycle Oversight Regulators assess not only analytical similarity but also the relevance of functional, pharmacokinetic/pharmacodynamics (PK/PD), immunogenicity, and, where warranted, clinical data. Moreover, PACs are subject to defined timelines, tracking, and sometimes conditional marketing authorization requirements. Key Regulatory Elements in Comparability and PAC Management Analytical Similarity Justification Comprehensive analytical characterization using orthogonal techniques to establish comparability post-change. Risk-Based Change Assessment Evaluation of process changes using science- and risk-based frameworks to determine regulatory reporting categories (e.g., prior approval vs. notification). Regional Variation Classification & Submission Strategy Mapping of the same change across FDA, EMA, and other authorities, taking into account local reporting types (Type IA/IB/II, CBE, PAS, etc.). Time-Bound PAC Tracking & Fulfillment Execution and documentation of post-approval studies (e.g., stability, immunogenicity, safety) to meet agency-imposed conditions or commitments. Regulatory Communication & Strategy Alignment Health authority interactions, pre-submission meetings, comparability protocol submissions, and coordinated response management. At Techsol, we bring deep regulatory insight and operational capability to manage complex lifecycle events for biologic and biosimilar products globally. We support strategic planning, technical documentation, and end-to-end execution of LCM activities. Our Core Services Include: Regulatory strategy for CMC changes and comparability assessments Compilation and submission of variation filings, supplements, or PACs across multiple markets Comparability Protocol (CP) preparation and submission (FDA) Development of regulatory justifications and impact assessments Integration of comparability and PAC data into RIM systems and QMS workflows Lifecycle tracking dashboards for regulatory deadlines, renewals, and variation approvals Global coordination for harmonized submissions and health authority queries Our Expertise and Value Proposition Regulatory-First Thinking We interpret regulatory changes and anticipate implications early—helping you plan and position your comparability and PAC strategy proactively. Cross-Market Alignment Our experts ensure your CMC variation strategies are harmonized across jurisdictions—minimizing redundant work and regulatory risk. Integrated Change & Data Management We align regulatory changes with internal QMS, change control records, and document systems for traceability and inspection readiness. Global Health Authority Engagement We prepare for and participate in regulatory interactions to support your comparability strategies to FDA Type C meetings or EMA Scientific Advice. Experience Across Modalities We’ve supported post-approval lifecycle management for a wide range of biologics, including mAbs, recombinant proteins, vaccines, enzymes, and biosimilars. Support for ongoing analytical and clinical development to support global filings At Techsol, we understand that robust analytical and clinical development is the cornerstone of successful global regulatory submissions. These critical processes generate the scientific evidence required to demonstrate product quality, safety, and efficacy — essential for obtaining regulatory approvals worldwide. Analytical Development encompasses the design, optimization, and validation of laboratory methods to rigorously test pharmaceutical products. This includes: Developing and validating analytical methods to accurately assess drug composition, potency, and purity Conducting stability studies that verify product integrity over its shelf life Generating reliable data to meet stringent regulatory quality standards Clinical Development involves comprehensive planning and execution of clinical trials and studies to evaluate a product’s safety and therapeutic efficacy. Our support covers: Designing clinical trial protocols tailored to regulatory expectations Managing data collection, analysis, and interpretation Providing clinical evidence to substantiate product benefits and risks in human populations Supporting Global Filings means preparing fully compliant and scientifically sound data packages tailored for submission to worldwide regulatory authorities such as the US FDA, EMA, PMDA, and others. This includes: Compiling analytical and clinical data into regulatory dossiers following region-specific guidelines Ensuring data integrity and consistency to facilitate smooth regulatory review Managing ongoing data updates and supplementary filings throughout the product lifecycle At Techsol, we understand that successful global regulatory submissions require a strong foundation of scientifically sound, regulatory-compliant analytical and clinical data. Our team provides strategic and operational support throughout the development lifecycle to help biopharma companies generate, manage, and submit high-quality data

Life Cycle Management Electronic Document & Data Management Request a Consultation Effective document and data governance is a foundational requirement for maintaining regulatory compliance throughout the product lifecycle. The integration of Electronic Document and Data Management (EDDM) within a Regulatory Information Management System (RIMS) provides a structured, validated environment for the creation, review, approval, and archiving of regulatory records. EDDM functionality within RIMS supports the end-to-end management of regulatory submissions, product registrations, and authority correspondence by centralizing all controlled documents and data assets. This enables organizations to ensure traceability, enforce version control, and uphold data integrity in alignment with applicable regulatory standards, including ICH, GxP, FDA 21 CFR Part 11, and EU Annex 11. Through automated workflows, secure access controls, and comprehensive audit trails, EDDM in RIMS enhances compliance oversight, reduces regulatory risk, and ensures ongoing inspection readiness across jurisdictions. Maintenance of Submission History and Product Lifecycle Data in Regulatory Information Management (RIM) Systems Maintaining robust and accurate submission history and product lifecycle data is essential to achieving regulatory compliance in an increasingly complex and globalized life sciences environment. Regulatory Information Management (RIM) systems serve as foundational tools that enable life sciences organizations to manage global regulatory data efficiently, ensuring traceability, transparency, and alignment with evolving health authority expectations. A well-configured RIM system acts as a central repository for managing the complete lifecycle of regulatory submissions and product registration data, supporting informed decision-making, timely compliance actions, and proactive health authority engagement. Key Features of RIM Data Maintenance Centralized Regulatory Intelligence: Stores and organizes all regulatory submissions, approvals, variations, renewals, and related documentation in a secure, accessible platform Submission History Tracking: Provides end-to-end visibility of original applications and all follow-up communications, amendments, and responses to health authority queries Lifecycle Event Management: Tracks key milestones such as product approvals, renewals, post-approval changes, labeling updates, and withdrawals Audit-Ready Recordkeeping: Maintains a complete audit trail of data changes, user actions, and system workflows, supporting global inspections Regulatory Compliance Monitoring: Ensures alignment with local and international guidelines, including FDA, EMA, Health Canada, and other health authorities Techsol’s Role in Regulatory Data Governance and RIM Maintenance Techsol provides specialized services to support the implementation, configuration, and maintenance of RIM systems across the product lifecycle. Our regulatory and technical teams partner with organizations to establish and maintain a consistent, audit-ready “single source of truth” for all regulatory submissions and lifecycle events. By ensuring that submission history, variations, renewals, and post-approval commitments are systematically tracked and updated, Techsol enables clients to meet global regulatory requirements and internal governance standards with confidence. Our Services Include: Submission History Compilation and Maintenance Product Registration and Lifecycle Tracking Data Cleansing, Standardization, and Migration RIM System Configuration and Workflow Optimization Integration with Regulatory Publishing, QMS, and Safety Systems Custom Dashboards and Compliance Reporting Our Expertise and Value Proposition Regulatory and Technical Expertise: Proficiency in leading RIM platforms including Veeva Vault RIM, ArisGlobal, and proprietary systems, enabling rapid implementation and effective system utilization Established Governance Frameworks: Deployment of structured data governance models to ensure standardization, auditability, and lifecycle continuity across the regulatory function Integrated Cross-Functional Collaboration: Alignment of regulatory operations with quality, pharmacovigilance, and clinical data flows to support a harmonized and compliant regulatory environment Scalable Global Service Delivery: Support for regional and enterprise-wide RIM initiatives through multilingual teams and scalable operating models that align with client geographies and timelines Regulatory Inspection Preparedness: Ensuring that regulatory data is consistently accurate, complete, and accessible—supporting readiness for audits, inspections, and health authority queries at any time Document Version Control, Archival, and Compliance with Regulatory Standards In highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, ensuring the integrity, traceability, and governance of regulatory information is not just a best practice—it’s a compliance mandate. Regulatory authorities worldwide, including the FDA, EMA, and other global agencies, require strict controls over the creation, review, approval, and retention of documentation throughout the product lifecycle. At Techsol, we understand these challenges. Our cutting-edge Regulatory Information Management (RIM) solutions integrate seamless Document Version Control, Archival, and Compliance features designed to keep your organization audit-ready and fully aligned with global regulatory standards like FDA 21 CFR Part 11, EMA eCTD, and ICH guidelines. With Techsol’s RIM system, regulatory teams gain complete control over document histories, ensure data integrity through precise version management, and maintain secure, accessible archives. This empowers your team to reduce compliance risks, accelerate regulatory submissions, and maintain readiness for inspections—supporting your mission to bring safe, effective products to market efficiently and confidently. Partner with Techsol to transform your regulatory information management into a strategic advantage in today’s complex regulatory landscape. Techsol’s Regulatory Information Management System (RIMS), integrated with advanced Electronic Document and Data Management (EDDM) capabilities, is purpose-built to meet these stringent expectations. Key Services Include: Version Control Management: Implementation of controlled version numbering, access permissions, and approval workflows to ensure that only authorized and validated versions are in use Audit Trails and Change History: Detailed logging of document creation, edits, reviews, approvals, and distribution activities for full traceability during inspections and audits Secure Document Archival: Long-term storage of regulatory documents in compliant, access-controlled repositories ensuring data integrity and disaster recovery readiness Regulatory Compliance Alignment: Adherence to global regulations including FDA 21 CFR Part 11, EMA Annex 11, and other regional standards governing electronic records and signatures Workflow Automation: Automated review and approval processes integrated with electronic document management systems (EDMS) to streamline compliance and reduce manual errors Document Retention and Disposition: Policies and processes for document retention periods, archival, and secure disposal aligned with regulatory and corporate requirements Reporting and Analytics: We set up dashboards and custom reports within Vault to monitor document statuses, outstanding actions, and compliance metrics in real-time Training and Change Management: Our experts provide hands-on Veeva Vault training and change management support, ensuring your team maximizes the platform’s potential while maintaining compliance Our Expertise and Value Proposition Expertise in Regulatory Document Management Standards: Our regulatory specialists and quality experts understand complex compliance requirements and apply best practices tailored to your operational needs Advanced

Life Cycle Management Global Market Expansion & Maintenance Our expertise lies in guiding companies through complex and evolving regulatory environments to ensure successful product registration and sustained compliance across diverse jurisdictions. Request a Consultation At Techsol, we enable life sciences and healthcare organizations to achieve and maintain global market access by providing strategic and operational regulatory support. Our expertise lies in guiding companies through complex and evolving regulatory environments to ensure successful product registration and sustained compliance across diverse jurisdictions. From initial development through post-market lifecycle management, our Regulatory Strategy and Operations team provides end-to-end support aligned with both regional regulatory nuances and global health authority standards. By combining in-depth subject matter expertise, region-specific insights, and sophisticated regulatory intelligence tools, we expedite approval timelines, reduce compliance risk, and ensure regulatory strategies are closely aligned with your business goals. Our approach includes: Global Regulatory Strategy Development Dossier Preparation & Submission Support Market Authorization Management Lifecycle Regulatory Maintenance Labeling Compliance & Change Management Regulatory Intelligence & Gap Analysis Techsol is your trusted partner in navigating regulatory complexity ensuring your products reach the right markets efficiently and remain compliant throughout their lifecycle. Country-Specific Dossier Adaptation for New Market Registrations Expanding into new markets requires more than just a globally accepted dossier—it demands meticulous adaptation of regulatory submissions to align with country-specific formats, guidelines, and authority expectations. At Techsol, we specialize in customizing regulatory dossiers to meet the unique requirements of individual health authorities across the globe. Our experienced Regulatory Affairs team ensures a smooth and compliant entry into new markets by tailoring content, structure, and data presentation based on local regulations. Our Services Include: Gap Analysis & Local Regulatory Intelligence Detailed comparison of the global/CTD dossier against target country requirements Identification of country-specific gaps, data needs, and formatting expectations Continuous tracking of regulatory updates and health authority communications Module-Level Adaptation & Authoring Customization of Modules 1–5 based on regional requirements (e.g., US FDA, EMA, TGA, PMDA, SFDA, ANVISA) Preparation of region-specific Module 1 administrative and legal documents Localization of product labels, patient leaflets, and risk management plans (RMPs) Dossier Formatting & Publishing Formatting dossiers in ICH/eCTD, NeeS, or paper-based formats, as applicable Lifecycle submissions (variations, renewals) adapted to local authority specifications Use of validated publishing tools to meet technical eCTD standards Regulatory Submission Support Preparation of cover letters, application forms, and submission-ready files Support for interactions with local agents or in-country regulatory representatives Tracking submission milestones and responding to agency queries Benefits of Country-Specific Dossier Adaptation Accelerates market entry by reducing submission rejections or delays Ensures full compliance with local regulatory laws, formats, and expectations Minimizes risk of regulatory pushback, deficiency letters, or rework Improves submission quality through structured, regionally optimized content Supports strategic market expansion by aligning with regulatory roadmaps Enables reuse of global content with minimal effort through smart adaptation Builds credibility with regulators by demonstrating regulatory maturity and preparedness Our Expertise and Value Proposition Global Regulatory Intelligence & Local Insight: Our team brings deep knowledge of region-specific regulatory frameworks and agency preferences, ensuring dossier packages are not only compliant but strategically positioned Seamless Integration with Global Submission Planning: Techsol aligns dossier adaptation with your global regulatory submission strategy, allowing for synchronized global launches or staggered submissions based on market priorities Experienced in Multi-Region Dossier Rollouts: We have supported dossier adaptations and submissions across North America, Europe, APAC, LATAM and Africa, navigating complex variations in regulatory expectations Flexible Resourcing and In-Country Support: Whether you need full ownership or supplemental support, we work closely with local affiliates, agents, and in-country regulatory consultants to bridge gaps in compliance and communication Quality-Driven, Efficient Execution: Through our robust quality systems, SOPs, and regulatory publishing expertise, Techsol ensures that each submission package is accurate, technically sound, and audit-ready Support for WHO prequalification and emerging market regulatory filings Techsol provides end-to-end regulatory support for World Health Organization (WHO) Prequalification (PQ) programs and regulatory submissions in emerging markets critical pathways for ensuring the availability of quality-assured, safe, effective and quality-assured medicines in resource-limited settings. Our regulatory team has extensive expertise in WHO PQ requirements and the regulatory frameworks of National Regulatory Authorities (NRAs) in regions such as Africa, Asia, and Latin America. We support applicants throughout the submission lifecycle, from technical dossier development and gap analysis to query responses and post-approval variations, ensuring full regulatory compliance with both global and local standards. By applying regulatory intelligence, regional expertise, and knowledge of collaborative registration mechanisms such as the WHO Collaborative Registration Procedure (CRP) and reliance-based models, we help streamline submissions, reduce approval timelines, and support global health access goals through compliant and efficient market entry strategies. Our Services Include WHO Prequalification Dossier Preparation & Submission Comprehensive gap analysis against WHO PQ dossier requirements Preparation and compilation of Module 1 tailored to WHO format Quality, clinical, and safety data alignment with WHO PQ standards Coordination of product samples, batch certifications, and stability data Management of the WHO PQ site inspections and queries Emerging Market Regulatory Strategy & Filings Customized regulatory intelligence and country-specific dossier adaptation for markets across Africa, Asia, Latin America, and the Middle East Preparation of regulatory dossiers in formats accepted by local authorities (e.g., paper, eCTD, NeeS) Support for registration, variation, and renewal submissions per regional timelines Local Regulatory Agency Liaison & Communication Engagement with national regulatory authorities and procurement bodies Management of queries, deficiency responses, and inspection facilitation Coordination with local agents, distributors, and partners for smooth filings Post-Submission Compliance & Lifecycle Support Ongoing monitoring of regulatory changes affecting WHO PQ and emerging market registrations Support for Pharmacovigilance, manufacturing site changes, and product renewals Maintenance of regulatory intelligence to anticipate emerging market trends and WHO updates Our Expertise and Value Proposition Specialized Expertise in WHO PQ & Emerging Markets: Our team has extensive experience managing WHO Prequalification dossiers and filings in markets across Africa, Asia, Latin America, and beyond, ensuring your products meet all necessary standards End-to-End Regulatory Support: From dossier compilation to submission tracking and query management, Techsol offers full lifecycle support for WHO

Life Cycle Management Chemistry, Manufacturing & Controls (CMC) Lifecycle Management We manage global CMC submissions, including variations, supplements, and amendments, aligning with regional Health Authority expectations. Request a Consultation At Techsol, our CMC regulatory experts provide strategic support throughout the product lifecycle, ensuring compliance with evolving global requirements. From post-approval changes to supply chain modifications, we help define and execute regulatory pathways that minimize risk and accelerate implementation. We manage global CMC submissions, including variations, supplements, and amendments, aligning with regional Health Authority expectations. Our proactive approach ensures data integrity, product quality, and uninterrupted market supply. Partner with us to navigate complex CMC challenges and maintain regulatory confidence at every stage. Our Key Services Include: CMC Strategy Development Dossier Authoring and Maintenance Change Management Support Technology Transfers and Site Changes Post-Approval Commitments & Compliance Global Harmonization of CMC Data Management of CMC changes across global markets At Techsol, the management of Chemistry, Manufacturing, and Controls (CMC) changes on a global scale entails comprehensive alignment with region-specific regulatory requirements to uphold product quality and regulatory compliance. This process demands strategic regulatory planning, rigorous documentation, and effective communication to address divergent approval pathways, timelines, and regulatory expectations. Robust CMC change management is critical to ensuring continuous product supply and regulatory lifecycle adherence. Regulatory authorities such as the FDA, EMA, PMDA, and NMPA enforce distinct regulatory frameworks, classifications, and submission requirements for CMC changes, necessitating a harmonized and strategically compliant global approach. Techsol’s regulatory experts partner with clients to: Precisely classify and evaluate the regulatory impact of proposed CMC changes Formulate customized, jurisdiction-specific regulatory submission strategies Facilitate cross-functional collaboration among Quality, Regulatory Affairs, and Supply Chain to ensure regulatory convergence Continuously monitor and interpret evolving regulatory guidance’s and approval mechanisms By leveraging in-depth regulatory intelligence, risk-based compliance assessments, and stringent project governance, Techsol ensures the timely preparation and submission of CMC change applications. This mitigates risks related to regulatory non-compliance, market interruptions, and approval delays. Organizations engaging Techsol benefit from a proactive, globally harmonized regulatory strategy for CMC changes, enabling sustained market supply, regulatory adherence, and agile response to an evolving regulatory environment. Our Services Include: Global CMC Change Impact Assessment Evaluation of CMC changes against ICH Q12 and local guidelines Classification of changes (major, moderate, minor) per region-specific regulatory frameworks (e.g., FDA, EMA, Health Canada, PMDA) Identification of required documentation and timelines for submission Variation Submission Planning & Management Strategic planning of global variation filings (Type IA/IB/II, Supplements, Notifications) Preparation of detailed CMC variation matrices aligned with product registration status Synchronization of global and local submission timelines to reduce delays and compliance risk Dossier Update & Technical Documentation Authoring and updating of Modules 2 & 3 with revised technical content Compilation of quality-related data including manufacturing process changes, specifications, stability data, analytical methods, and site information Coordination with CMC teams, QA, and manufacturing for accurate data collection Regulatory Submission & Lifecycle Management Submission of CMC changes via eCTD, NeeS, or paper formats based on regional authority requirements Post-submission support including query response management and commitment tracking Maintenance of submission logs and change history across the product lifecycle Our Expertise and Value Proposition Global Regulatory Intelligence & Experience: Techsol has supported hundreds of CMC change submissions across regulated and semi-regulated markets, with expertise in both centralized and decentralized submission pathways Structured CMC Change Control Workflow: Our team integrates seamlessly with client quality and manufacturing systems, using well-defined processes to evaluate, document, and communicate changes efficiently Strong Understanding of Country-Specific Guidelines: We maintain up-to-date knowledge of regulatory requirements across over 50 countries, including EU Variations Regulation, US FDA Guidance, WHO TRS, and more Technical Writing Expertise: Our regulatory professionals are skilled in translating complex manufacturing changes into clear, compliant, and submission-ready documents for Module 3 and related sections Global Submission Coordination: Techsol helps you manage multiple market variations in parallel, aligning global and local regulatory strategies while minimizing duplicated effort and inconsistencies Risk-Based Approach to CMC Strategy: We incorporate risk management principles (per ICH Q9/Q12) to prioritize changes and develop regulatory pathways that balance speed with compliance Compilation of Module 3 Content and Supporting Documentation Module 3 of the Common Technical Document (CTD) constitutes a fundamental element of regulatory submissions, detailing the Chemistry, Manufacturing, and Controls (CMC) information essential for regulatory evaluation. This module encompasses critical data on the drug substance, drug product, and manufacturing processes, enabling regulatory authorities to rigorously assess product quality, manufacturing consistency, and safety compliance. Techsol offers specialized regulatory services for the compilation, authoring, and submission of updated Module 3 content as part of post-approval maintenance, lifecycle changes, and global market expansion efforts. Our experts ensure that updates to Module 3 are accurately compiled, scientifically justified, and compliant with regional regulatory requirements whether for new submissions, supplements, variations, renewals, or Health Authority responses. Our Services Include: Content Authoring for Module 3 Sections Integration of Post-Approval Changes Gap Assessment and Remediation Data Harmonization Across Markets Supporting Documentation Preparation Regulatory Publishing and Submission Readiness Our Expertise With a dedicated team of experienced regulatory professionals and CMC specialists, Techsol provides comprehensive support for Chemistry, Manufacturing, and Controls (CMC) activities throughout the product lifecycle. Our deep expertise in global regulatory requirements ensures that all post-approval changes are strategically planned, accurately documented, and fully compliant with Health Authority expectations, enabling seamless submissions and sustained market authorization. Extensive CMC and Regulatory Expertise: Our CMC and regulatory experts will integrate scientific, technical, and regulatory expertise to ensure that Module 3 content is accurately compiled, structurally compliant, and fully aligned with the applicable requirements of regional and international Health Authorities Seamless and Efficient Dossier Updates: We have deep experience in integrating post-approval changes without introducing inconsistencies or redundant updates, ensuring submission clarity and regulatory acceptability Comprehensive Lifecycle Management: From initial change assessment to final submission and authority interactions, Techsol provides end-to-end support for Module 3 management and regulatory compliance across product lifecycle stages Audit-Ready Documentation: Our team consistently delivers high-quality documentation prepared to withstand the scrutiny of global regulatory inspections and rigorous submission evaluations Site Transfers, Equipment

Life Cycle Management End-to-end regulatory support across the full product life cycle Effective Life Cycle Management (LCM) is a regulatory imperative for sustaining product quality, maintaining compliance, and ensuring uninterrupted market presence. Request a Consultation Regulatory Life Cycle Management At Techsol, we deliver end-to-end regulatory support across the full product life cycle from initial marketing authorization through post-approval maintenance and global expansion. Effective Life Cycle Management (LCM) is a regulatory imperative for sustaining product quality, maintaining compliance, and ensuring uninterrupted market presence. Our LCM services encompass a broad range of post-approval regulatory activities, including: Preparation and submission of regulatory variations, supplements, and renewals in alignment with regional requirements Management of Chemistry, Manufacturing, and Controls (CMC) updates, safety-related changes, and labeling modifications Development and execution of globally harmonized change control strategies Continuous monitoring of regulatory landscapes and impact assessments for proactive compliance Adherence to evolving international and local regulatory guidelines and frameworks Through a strategic, risk-based regulatory approach, Techsol enables sponsors to maintain the compliance integrity of their products, reduce regulatory delays, and adapt effectively to changes in requirements. Our integrated global support ensures consistent regulatory engagement and timely execution of life cycle activities across all relevant markets. Post-Approval Supplements At Techsol, we specialize in providing comprehensive regulatory support for the preparation and submission of Post-Approval Supplements (PAS) to ensure ongoing compliance with FDA requirements. As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly. Our regulatory team manages all supplement types including CBE-0, CBE-30, and Prior Approval Supplements (PAS) supporting changes related to manufacturing processes, formulation, labeling, and packaging. We ensure proper classification of each change, complete and accurate dossier preparation, and timely submission to facilitate FDA review, reduce approval timelines, and maintain uninterrupted product availability. Our Services Includes: Techsol supports all categories of FDA post-approval supplements, with precision and compliance at the core of our services: CBE-0 (Changes Being Effected – Immediate Implementation): Submissions for changes that may be implemented immediately upon FDA receipt. Our team prepares and submits supporting documentation concurrently to meet regulatory expectations. CBE-30 (Changes Being Effected in 30 Days): For moderate changes, Techsol ensures submission of all required data 30 days prior to implementation, enabling clients to proceed with confidence upon FDA clearance. PAS (Prior Approval Supplements): For significant changes requiring FDA review and approval before implementation, our regulatory experts craft robust submission packages to minimize review cycles and mitigate risk of delays. Our Expertise At Techsol, we bring deep regulatory expertise and a proactive approach to managing post-approval changes across global markets. Here’s why leading pharmaceutical companies trust us: End-to-End Support: From strategy development to submission and agency follow-up, we manage the complete lifecycle of post-approval changes Global Regulatory Expertise: Proficient in FDA, EMA, and other major regulatory authorities’ requirements for supplements, variations, and amendments Accurate Change Classification: We perform impact assessments and determine the correct supplement type, reducing the likelihood of FDA rejections or resubmissions Submission Excellence: Our team delivers fully compliant, submission-ready dossiers (eCTD/NeeS), ensuring timely and successful filings Variations (Type IA, IB, II for EU, CP/MRP/DCP/National) Effective lifecycle management of medicinal products within the EU requires a structured and compliant approach to handling regulatory variations. Changes to the terms of a marketing authorization (MA) are classified by the European Medicines Agency (EMA) and national competent authorities into Type IA, Type IB, and Type II variations, based on the potential impact on product quality, safety, and efficacy. Each variation type is governed by specific regulatory guidelines, defined timelines, and procedural requirements. Regulatory strategies must align with the applicable submission routes Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), or purely National procedures to ensure timely implementation and uninterrupted product availability. At Techsol, we provide end-to-end regulatory support for the classification, preparation, and submission of variations in accordance with the European Union (EU) regulatory framework, enabling Marketing Authorization Holders (MAHs) to maintain ongoing compliance while efficiently managing post-approval product changes. Our regulatory experts ensure precise determination of variation type, appropriate documentation, and adherence to procedural requirements, whether changes are administrative, quality-related, or impact the safety or efficacy of the product. Techsol Expertise Across EU Variation Types We provide regulatory support across all categories of EU variation submissions: Type IA Variations: Minor changes with no significant impact on quality, safety, or efficacy. These are submitted as post-implementation notifications, without requiring prior approval from the competent authority Type IB Variations: Moderate changes that are not classified as Type IA or Type II. These require prior notification and regulatory assessment. Techsol ensures accurate variation scope definition and timely submission to avoid review delays Type II Variations: Major changes that may significantly affect product quality, safety, or efficacy. These require a comprehensive scientific evaluation, and we support dossier preparation, justification development, and authority engagement for favorable outcomes Support Across All EU Regulatory Procedures Techsol manages variation submissions through all applicable EU regulatory pathways: Mutual Recognition Procedure (MRP): For products authorized in one Member State, we coordinate submission to the RMS, manage communication with CMS, and support responses to regulatory questions for recognition across additional Member States. Decentralized Procedure (DCP): For new products seeking parallel approvals in multiple EU Member States, we manage dossier preparation, procedural timelines, and regulatory interactions to ensure a harmonized review and approval process. National Procedure: For country-specific variations, we adapt submission strategies to meet national requirements and maintain close coordination with local health authorities to secure timely approvals. Value Proposition Regulatory Precision: In-depth knowledge of EU regulatory frameworks, variation classification rules, and procedural nuances. Comprehensive Submission Management: From dossier compilation to post-submission follow-up, we ensure seamless execution. Multi-Country Coordination: Expertise in handling MRP/DCP/National procedures and regulatory correspondence across multiple markets. Renewals and Reassessments MA Renewals are regulatory submissions required to extend the validity of a product’s marketing authorization after its initial approval period (commonly 5 years in the EU and many other regions). After the renewal is granted, the authorization typically becomes indefinite, provided the product continues to meet regulatory requirements. Reassessments are formal

Content Authoring Services Clinical Content Authoring Our expertise enables sponsors to deliver accurate, submission-ready documents that withstand regulatory scrutiny and accelerate clinical development timelines. Request a Consultation Overview At Techsol Life Sciences, we specialize in developing high-quality, regulatory-compliant clinical content to support global submissions for pharmaceuticals, biologics, medical devices, and Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies. Our clinical writing team provides end-to-end authoring, compilation, and submission support for critical clinical documents, ensuring alignment with ICH E3, E6(R2), and M4E(R2) guidelines, as well as evolving FDA, EMA, PMDA, Health Canada, and CDSCO requirements. Our expertise enables sponsors to deliver accurate, submission-ready documents that withstand regulatory scrutiny and accelerate clinical development timelines. Techsol Expertise in Clinical Regulatory Content Authoring Techsol has extensive experience in authoring a full suite of clinical regulatory documents that demonstrate efficacy, safety, and risk–benefit to support global submissions: IND/IMPD Submissions: Clinical sections (Module 2.5 & 2.7), clinical trial protocols, IBs, and clinical study reports to support first-in-human and early-phase studies. NDA/BLA/MAA Submissions: Clinical summaries, Integrated Summaries of Safety (ISS) and Efficacy (ISE), clinical overview, and pivotal clinical study reports supporting product approval and labeling claims. Gene Therapy and ATMP Submissions: Specialized authoring for clinical trial protocols, LTFU plans, and clinical summaries addressing long-term safety, immunogenicity, shedding, and efficacy in line with FDA 2023 guidance and EMA CAT requirements. Clinical CTD Structure and Key Documents Our clinical authoring aligns with ICH M4E (Module 2 and 5) and eCTD structure: 1. Clinical Overview (Module 2.5) Integrated summary of clinical development, efficacy, and safety Benefit-risk evaluation for regulatory decision-making 2. Clinical Summaries (Module 2.7) 2.7.1 Summary of Biopharmaceutics & Associated Analytical Methods 2.7.2 Summary of Clinical Pharmacology Studies (PK/PD) 2.7.3 Summary of Clinical Efficacy 2.7.4 Summary of Clinical Safety (including ISS/ISE integration) 3. Clinical Study Reports and Supporting Documents (Module 5) ICH E3-compliant clinical study reports (Phase 1–3, BA/BE, special populations) Integrated safety and efficacy reports for pivotal trials Patient narratives and appendices for regulatory submissions Templates and Authoring Standards Techsol templates comply with: ICH M4E and eCTD Module 5 for clinical documentation US FDA eCTD v4.0, EMA Module 5, PMDA and Health Canada formats Tech-enabled authoring with: Standardized CSR and summary templates Integrated tabular and graphical data for readability Secure document management through RIMS or VeevaVault Clinical Authoring Workflow at Techsol 1. Source Data Collection and Study Report Compilation Collect final TLFs (Tables, Listings, Figures), clinical database extracts, and statistical outputs Ensure traceability from raw data to summary tables and narratives 2. Drafting Clinical Summaries and Overviews Prepare Modules 2.5 and 2.7 using Techsol’s validated templates Integrate statistical results, visual data displays, and safety narratives for clarity 3. Internal QC and Peer Review Line-by-line QC for data accuracy and alignment with CSR/statistical outputs Cross-check with protocols and SAP to ensure consistency 4. SME and Regulatory Review Clinical, biostatistics, and regulatory SME review for scientific and compliance accuracy Alignment with FDA, EMA, and ICH expectations for clinical content 5. Finalization and eCTD Publishing Seamless integration into Modules 2 and 5 for IND, NDA, BLA, or MAA submissions Pre-submission validation to ensure eCTD compliance and regulatory readiness Common Challenges and Techsol Solutions Challenges Techsol Solutions Inconsistent terminology across clinical study documents Standardized glossaries, document harmonization, and cross-referencing Linking safety and efficacy data for ISS/ISE Evidence-based integration with clear benefit-risk narrative Formatting or traceability errors in eCTD Automated eCTD validation and QC-driven publishing Tight submission timelines for pivotal studies Parallel authoring and QC workflows leveraging dedicated medical writers and statisticians Techsol Clinical Writing Capabilities & Value Proposition Highly qualified clinical medical writers: With advanced degrees (M.D., Ph.D., Pharm.D., M.Sc.) and expertise in clinical pharmacology, statistics, and regulatory writing Strong regulatory acumen: Across ICH E3/E6, FDA, EMA, PMDA, and Health Canada requirements Integrated project management: Ensuring milestone adherence, communication efficiency, and risk mitigation Tech-enabled workflow: With validated templates, version control, and secure document management systems End-to-end value: From gap analysis to final eCTD submission-ready deliverables, ensuring high-quality, regulator-ready clinical documentation that accelerates approvals Content Authoring Services Regulatory Briefing Documents Read More CMC Content Authoring Read More Non-Clinical Content Authoring Read More Request a Demo Submit

Content Authoring Services Non- Clinical Content Authoring  Request a Consultation Overview At Techsol Life Sciences, we specialize in developing regulatory-compliant non-clinical overviews, summaries, and study reports, offering end-to-end support for authoring, compilation, and submission of high-quality, submission-ready documentation. Leveraging our in-depth knowledge of global health authority requirements and evolving international regulatory expectations, including ICH guidelines, we ensure seamless preparation of non-clinical content that enables sponsors to confidently navigate complex regulatory landscapes and achieve successful submissions. Techsol Expertise in Non-Clinical Regulatory Content Authoring Techsol has extensive experience in developing non-clinical documentation that is pivotal for demonstrating the safety and supporting the risk assessment of pharmaceuticals, biologics, and Advanced Therapy Medicinal Products (ATMPs), including complex cell and gene therapies. For INDs (Investigational New Drug Applications), the non-clinical package supports first-in-human (FIH) studies by demonstrating that the therapy is reasonably safe to proceed. For NDAs (New Drug Applications) and BLAs (Biologics License Applications), non-clinical content substantiates the comprehensive safety profile and supports labeling claims. Gene Therapy and ATMP Submissions require specialized non-clinical assessments focusing on biodistribution, shedding, immunogenicity, tumorigenicity, insertional mutagenesis, and long-term follow-up (LTFU) per FDA Guidance (2023) and EMA CAT requirements. Non-Clinical CTD Report Structure Non-clinical reports are structured according to ICH M4S (Safety) and eCTD Module 4, which typically includes: 1. Non-Clinical Overview (Module 2.4) Executive summary of pharmacology, pharmacokinetics (PK), and toxicology Integrated risk assessment highlighting safety margins and clinical translation relevance 2. Non-Clinical Written and Tabulated Summaries (Module 2.6) Pharmacology Summary (Primary, Secondary, and Safety Pharmacology) Pharmacokinetics Summary (ADME, bioavailability, tissue distribution) Toxicology Summary (Single-dose, repeat-dose, genotoxicity, reproductive, and carcinogenicity studies) 3. Individual Study Reports (Module 4) GLP-compliant study reports (e.g., toxicology, safety pharmacology, genotoxicity, carcinogenicity, immunogenicity) Specialized reports for gene therapy and biologics, including: Biodistribution Studies Viral Shedding Studies Integration/Insertional Mutagenesis Reports Tumorigenicity and Reproductive Toxicity (if applicable) Nonclinical Pharmacokinetic/ADME Reports Templates and Authoring Standards Techsol uses standardized templates based on: ICH M4S and eCTD structure for small molecules and biologics Gene Therapy / ATMP-specific templates integrating long-term follow-up (LTFU) and risk management sections Content aligned with latest regulatory requirements: US FDA eCTD v4.0 EMA Module 4 requirements and CAT recommendations for ATMPs Japan PMDA and Health Canada eCTD adaptations Non-Clinical Authoring Workflow at Techsol 1. Source Data Collection, and Authoring Gather GLP-compliant study reports, bioanalytical data, and pharmacology summaries Ensure traceability from raw data to CTD summaries 2. Drafting Non-Clinical Summaries and Overviews Prepare Module 2.4 and 2.6 using Techsol’s regulatory templates Integrate tabulated and graphical data for clarity 3. Internal QC and Peer Review Line-by-line QC to ensure data accuracy, consistency with study reports, and adherence to ICH format Cross-referencing with clinical protocols to ensure translational relevance 4. SME and Regulatory Review Review by toxicologists, pharmacologists, and regulatory SMEs Alignment with latest FDA and EMA guidance for non-clinical content 5. Finalization and eCTD Publishing & Submission Integration into Module 4 for IND, NDA, or BLA submissions eCTD validation before submission to health authorities Common Challenges and Techsol Solutions # Challenges Solutions 1 Inconsistent terminology and abbreviations across the source documents provided. To ensure consistency and avoid redundancy across the non-clinical documents, standardized glossaries and abbreviation lists are used along with document harmonization, strategic planning, targeted cross-referencing, and content streamlining. 2 Difficulty aligning nonclinical findings with clinical safety conclusions. Authoring of clear, evidence-based conclusions in Module 2.4, 2.6, and 4. Linking nonclinical safety signals to potential clinical risks or mitigation strategies. 3 Technical formatting errors in final deliverables. Automated tools for document validation (bookmarks, hyperlinks, metadata), Pre-submission publishing checks for eCTD compliance. 4 Errors in tabulation or data presentation. Dedicated QC and editorial teams to ensure technical accuracy and formatting consistency, automated cross-checks, and validation steps. Expertise and Capabilities of Techsol Qualified Nonclinical Medical Writers: Experts with advanced degrees (Ph.D., Pharm.D., M.Sc.) and cross-domain experience in pharmacology, toxicology, and DMPK Regulatory Acumen: Proficiency in ICH, OECD, FDA, EMA, and WHO guidelines Project Management Excellence: Streamlined communication, milestone tracking, and risk mitigation strategies Tech-driven Workflow: Use of validated authoring templates, version tracking systems, and secure document management platforms (e.g., RIMS, Veeva Vault) Value Proposition Deep scientific expertise in nonclinical domains ensures high-quality, interpretation-driven content. Proven experience with US FDA, EMA, PMDA, and CDSCO regulatory expectations. From data gap analysis to eCTD publishing support, all under one roof. Rigorous QC and review cycles ensure submission-ready deliverables. Adaptable resourcing models and collaborative project management practices. Content Authoring Services Regulatory Briefing Documents Read More CMC Content Authoring Read More Clinical Content Authoring Read More Request a Demo Submit

Content Authoring Services CMC Content Authoring Our CMC authoring solutions are strategically tailored to meet the evolving expectations of health authorities worldwide, including the FDA, EMA, MHRA, Health Canada, PMDA (Japan), and TGA (Australia). Request a Consultation Overview At Techsol Life Sciences, we deliver end-to-end Chemistry, Manufacturing, and Controls (CMC) regulatory authoring services designed to support the entire product lifecycle—from early-stage development and clinical trial initiation to global marketing authorization and post-approval lifecycle management. Our CMC authoring solutions are strategically tailored to meet the evolving expectations of health authorities worldwide, including the FDA, EMA, MHRA, Health Canada, PMDA (Japan), and TGA (Australia). Leveraging up-to-date regulatory intelligence, ICH M4Q guidelines, and eCTD submission standards, we ensure that every document we produce is scientifically robust, compliant, and submission-ready. We specialize in authoring CMC documentation for: Global drug development submissions: IND, CTA, NDA, BLA, MAA Marketing authorizations and post-approval variations across major regions Lifecycle management submissions for: Small molecules Biologics and biosimilars Vaccines Advanced cell and gene therapies (ATMPs) Investigational Stage CMC Content Authoring At the early clinical development phase, CMC documentation plays a critical role in demonstrating product quality, manufacturing control, and regulatory compliance for First-in-Human (FIH) trials. Techsol CMC Authoring Scope for Early Phase Submissions Submission Type Techsol Authoring Scope IND (FDA) • Comprehensive Module 3 authoring for investigational products • Manufacturing processes and in-process controls • Analytical methods, specifications, and validation reports • Stability study protocols & reports • Comparability and bridging assessments for manufacturing or site changes CTA (EMA, Health Canada, Global) • CMC modules for EU, Canada, and RoW trial applications • Drug substance & drug product quality documentation • IMP Quality & Analytical validation summaries • IMPD (Investigational Medicinal Product Dossier) preparation and updates Marketing Authorization & Commercial Stage As products advance toward pivotal trials and commercial readiness, CMC documentation must comprehensively demonstrate process validation, quality assurance, and robust commercial-scale manufacturing controls. Leveraging the latest ICH Q12 & Q 13 lifecycle management principles, Techsol’s expertise in authoring Module 3 and Quality Overall Summaries (QOS) ensures dossiers are scientifically clear, regulator-ready, and optimized to minimize deficiency letters. This proactive, compliance-driven approach enhances dossier quality, accelerates approval timelines, and supports seamless product lifecycle management for global submissions. Techsol CMC Authoring Scope for Late-Phase & Commercial Submissions Submission Type Techsol Authoring Scope NDA (FDA) • Full Module 3 authoring, linked to nonclinical and clinical modules • Quality Overall Summary (QOS, Module 2) • Process validation & control strategy documentation • Alignment with FDA Quality by Design (QbD) & PQS principles ANDA (FDA) • Generic product CMC dossier authoring • Bioequivalence & quality documentation • Analytical & stability method validation reports • eCTD publishing for Type II DMFs BLA (FDA) • Comprehensive CMC documentation for biologics, vaccines, and ATMPs • Comparability & change control strategies • Process validation aligned with FDA CMC Guidance for Biologics (2023 update) MAA (EMA) • CTD-aligned CMC dossier preparation for EU submission • QOS (Module 2) and country-specific annexes • Alignment with EMA/CHMP post-Brexit and EU ATMP guidance Lifecycle Management & Supporting CMC Authoring Services Overview Beyond initial product approvals, proactive post-approval CMC lifecycle management is critical to maintaining regulatory compliance, ensuring uninterrupted product supply, and supporting global lifecycle continuity. Techsol provides comprehensive strategic support for all types of Drug Master Files (DMFs) and equivalent regional submissions. Techsol’s expertise covers the authoring, maintenance, and annual updates for US FDA DMFs, including Type II (Drug Substances), Type III (Packaging Materials), Type IV (Excipients and Colorants), and Type V (FDA-Accepted Reference Information). We also prepare Active Substance Master Files (ASMFs) for EMA submissions, including both the Applicant Part (AP) and Restricted Part (RP) to protect confidential proprietary information. Additionally, we manage a full spectrum of post-approval CMC activities, including supplements, variations, site transfers, process improvements, technology transfers, and lifecycle changes, in alignment with the latest FDA CMC Post-Approval Changes Guidance (2023), EMA Variations Regulation (EC 1234/2008), and global regulatory convergence initiatives. This end-to-end approach ensures high-quality, regulator-ready submissions that minimize agency queries, expedite approvals, and maintain continuous compliance throughout the product lifecycle worldwide. Techsol’s Expertise in Post-Approval CMC Lifecycle Management and Regulatory Authoring At Techsol Life Sciences, we offer end-to-end regulatory support across the entire CMC lifecycle, ensuring continuous global compliance, faster approvals, and minimized regulatory risk. Leveraging our deep expertise and the latest regulatory frameworks—including ICH Q12/Q13, FDA CMC Post-Approval Changes Guidance (2023), and EMA Variations Regulation (EC 1234/2008)—we help sponsors maintain uninterrupted product supply and achieve seamless lifecycle management. Post-Approval CMC Lifecycle Management Techsol specializes in regulatory change management, including the preparation and submission of US FDA Post-Approval Supplements, EU Variations, and Global Change Notifications (ROW), with precise classification of changes (major, moderate, minor) per ICH Q12 and regional guidance. Our team leads manufacturing site transfers, technology transfers, and scale-up activities, supported by robust comparability protocols and regulatory filings to ensure product continuity. We also manage process optimization and continuous improvement initiatives, including equipment upgrades, raw material changes, and automation, fully aligned with Quality by Design (QbD) and Continued Process Verification (CPV). Additionally, we author Post-Approval Change Management Protocols (PACMPs) to enable proactive lifecycle change implementation and minimize regulatory uncertainty. CMC Dossier & Regulatory Document Authoring Our regulatory writing team delivers high-quality, agency-ready CMC submissions, including: Module 2 Quality Overall Summaries (QOS) that are concise, regulator-focused, and aligned with ICH M4Q and regional formats. Module 3 Quality Sections covering drug substance and drug product, including process validation, control strategies, analytical methods, and stability data. Supporting global submission documents, such as comparability reports, bridging justifications, and responses to agency information requests, ensuring clarity and faster regulatory review. DMF / ASMF / CEP Preparation & Maintenance Techsol provides comprehensive DMF and regional dossier lifecycle support to meet global regulatory expectations: US FDA DMFs (Type II, III, IV, and V) – Authoring, maintenance, annual updates, and Letter of Authorization (LOA) management. EMA Active Substance Master Files (ASMFs) – Preparation of Applicant Part (AP) and Restricted Part (RP) with complete lifecycle updates and agency responses. EDQM Certificates of Suitability

Content Authoring Services Regulatory Briefing Documents We combine deep expertise in regulatory writing, submission, and electronic publishing to prepare high-quality briefing packages for formal meetings with global health authorities. Request a Consultation Overview Regulatory Briefing Documents are comprehensive, scientifically rigorous, and strategically crafted dossiers that enable structured communication between pharmaceutical, biotechnology, and medical device sponsors and global health authorities. These documents serve as a critical component of regulatory interactions, acting as the primary written medium through which sponsors present development status, scientific rationale, risk assessments, and key decision points for regulatory consideration. At Techsol Life Sciences, we combine deep expertise in regulatory writing, submission, and electronic publishing to prepare high-quality briefing packages for formal meetings with global health authorities, including: US FDA (Food and Drug Administration) EMA (European Medicines Agency) MHRA (UK Medicines and Healthcare products Regulatory Agency) Health Canada PMDA (Japan), TGA (Australia), and other regional authorities Our briefing documents are meticulously designed to clearly communicate the scientific narrative and regulatory strategy, enabling regulators to make timely and informed decisions that advance product development. Purpose of Regulatory Briefing Documents In today’s evolving regulatory landscape, Regulatory Briefing Documents are critical for driving efficient product development and approvals. These documents enable data-driven dialogue with health authorities, fostering early alignment and reducing uncertainties in the review process. By proactively addressing potential agency concerns, sponsors can mitigate regulatory risks before they impact development timelines. Leveraging global harmonization and regulatory convergence initiatives such as ICH, Project Orbis, and the ACCESS Consortium, high-quality, agency-ready briefing documents not only accelerate market entry but also enhance sponsor credibility by demonstrating scientific rigor and regulatory excellence. Common Regulatory Meetings Supported by Briefing Documents Meeting Type Health Authority Regulatory Objective Pre-IND Meeting FDA Discuss first-in-human readiness, CMC status, and Initial clinical plan End-of-Phase 2 (EOP2) FDA Confirm Phase 3 study design, endpoints, and statistical approach Pre-NDA / Pre-BLA FDA Align final submission content, risk mitigation plans, and labeling approach Type C Meeting FDA Address specialized development issues or emerging safety concerns Scientific Advice Meeting EMA Seek guidance on study design, pediatric plans, and CMC strategy National Scientific Advice Health Canada / MHRA Confirm regional requirements and mitigate regulatory risks Structure of Briefing Document: A well-structured briefing document facilitates clear regulatory decision-making and maximizes the value of sponsor-agency interactions. Techsol follows a globally accepted structure tailored to FDA, EMA, PMDA, and other agency requirements: 1. Introduction & Meeting Objectives Defines the purpose of the meeting (Type A/B/C for FDA, Scientific Advice for EMA). States expected outcomes, key discussion points, and desired regulatory alignment. 2. Product & Development Background Provides a concise product profile: mechanism of action, target indication, unmet medical need. Summarizes prior regulatory interactions, designations (e.g., ODD (Orphan Drug Designation), RMAT (Regenerative Medicine Advanced Therapy)), and approval history if applicable. 3. CMC Overview Presents manufacturing process, control strategy, comparability studies, and stability data. Addresses emerging expectations for Quality by Design (QbD), lifecycle management, and global harmonization (ICH Q12). 4. Nonclinical Summary Highlights pivotal pharmacology, toxicology, and safety studies. Addresses any species-specific findings, NOAEL justification, and translational relevance to clinical studies. 5. Clinical Summary Provides integrated efficacy and safety data, PK/PD findings, and dose-selection rationale. Includes status of ongoing studies, interim analyses, and data to support accelerated or conditional approvals. 6. Integrated Risk-Benefit Discussion Summarizes known and potential risks, safety signals, and mitigation strategies. Provides quantitative benefit-risk assessment aligned with FDA and EMA expectations for structured benefit-risk evaluation. 7. Key Questions for Regulatory Feedback Clearly framed to solicit constructive and actionable input from the agency. Tailored to avoid clinical holds, confirm pivotal study designs, or align on CMC readiness for Phase 3 / BLA / MAA submission. 8. Proposed Development / Submission Plan Outlines next regulatory milestones, study timelines, and potential expedited pathways (Priority Review, PRIME, SAKIGAKE, etc.). Incorporates global submission strategy to optimize market entry and minimize redundant studies. 9. Appendices Provides comprehensive supporting data, tables, figures, datasets, and references to ensure transparency.   Techsol’s Expertise in Regulatory Briefing Document Development Techsol Life Sciences has extensive experience in developing high-quality Regulatory Briefing Documents that support critical interactions with global health authorities. We have successfully authored and published briefing packages for: First-in-class small molecules and biologics requiring novel regulatory strategies Orphan drugs and fast-track products leveraging expedited approval pathways (e.g., FDA Fast Track, Breakthrough Therapy, EMA PRIME) Complex generics and combination products including inhalation therapies, injectables, and device-drug combinations Cell and gene therapy submissions aligning with evolving regulatory frameworks (e.g., ATMP (Advanced Therapy Medicinal Product) guidance in the EU, FDA CBER guidelines) Content Authoring Services CMC Content Authoring Read More Non-Clinical Content Authoring Read More Clinical Content Authoring Read More Request a Demo Submit

Regulatory Operations Risk Management Services Our expert team ensures that your RMP & REM clearly outlines the safety profile of your product and includes appropriate strategies to minimize risk throughout its lifecycle. Request a Consultation At Techsol Life Sciences, we help pharmaceutical and biotech companies develop, submit, and maintain Risk Management Plans (RMPs) in compliance with European Medicines Agency (EMA) and other global regulatory requirements. Our expert team ensures that your RMP clearly outlines the safety profile of your product and includes appropriate strategies to minimize risk throughout its lifecycle. Overview on RMP? A Risk Management Plan is a regulatory document required by the EMA (and other health authorities) to describe: Identified and potential safety concerns Plans to monitor and minimize risks Methods to evaluate the effectiveness of risk minimization strategies RMPs are mandatory for new Marketing Authorization Applications (MAAs) in the EU and are part of ongoing pharmacovigilance obligations. Techsol’s RMP Development Services RMP Authoring & Preparation Drafting of RMPs according to EU GVP Module V and EMA templates Integration of data from clinical trials, post-marketing safety reports, and risk-benefit evaluations Inclusion of Safety Specifications, Pharmacovigilance Plans, and Risk Minimization Measures RMP Review & Gap Analysis Reviewing existing RMPs for regulatory compliance and completeness Identifying gaps and aligning with the latest EMA guidelines or PSUR findings Ensuring consistency with product labeling and safety reports RMP Submission & Lifecycle Management Submission of RMPs as part of initial MAAs or variations Updates to RMPs following new safety data, product changes, or authority requests Ongoing tracking and maintenance throughout the product’s life cycle Global RMP Alignment While RMPs are primarily a requirement in the EU, other countries (e.g., Saudi Arabia, Australia, and Canada) have similar risk management requirements. Techsol helps ensure your plans are globally aligned to meet diverse market expectations. Challenges associated with a Risk Management Plan (RMP) Global Differences in RMP Requirements: Regulatory authorities across regions often have unique expectations and may require additional risk minimization strategies, making it challenging for companies to create a universally applicable RMP. Designing Effective Risk Minimization Measures: Developing practical, measurable, and product-specific minimization without overburdening stakeholders is difficult. Timely Updates and Lifecycle Management: RMPs must be updated proactively based on new safety data, label changes, or regulatory requests. Techsol’s Approach to Simplifying RMP Challenges At Techsol, we simplify RMP development and maintenance by: Providing expert guidance on region-specific and global RMP requirements Assisting with risk identification and data evaluation Designing custom risk minimization plans aligned with product use and target population Ensuring consistency across RMPs, safety reports, and labeling Supporting timely RMP updates during post-approval changes or authority feedback Techsol Expertise in RMP Services Skilled medical writers with in-depth safety and regulatory expertise Experience in multi-region submissions and post-authorization safety updates Strategic insights into linking RMPs with Risk Evaluation and Mitigation Strategies (REMS), PSURs, and PBRERs At Techsol Life Sciences, we support pharmaceutical and biotech companies in developing and implementing FDA-compliant Risk Evaluation and Mitigation Strategies (REMS) to ensure the safe use of drugs with known or potential serious risks. Our regulatory experts provide end-to-end REMS planning, submission, and maintenance services across the product lifecycle. Risk Evaluation and Mitigation Strategy (REMS) is a regulatory program required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to help ensure that the benefits of the drug outweigh its risks. REMS programs are designed to manage specific risks by reinforcing safe use conditions through communication, training, and monitoring. A REMS may be required during: Initial drug approval Post-market safety evaluation New information on known risks Techsol’s REMS Support Capabilities Techsol has a full range of capabilities and extensive experience supporting REMS programs for clients, including: REMS Needs Assessment Analyze drug safety profile and therapeutic indication Evaluate whether REMS is required per FDA guidance Conduct comparative risk analysis based on similar marketed products REMS Document Preparation Author REMS documents, including goals, elements to assure safe use (ETASU), communication plans, implementation systems, and assessment metrics Prepare REMS Supporting Documents (RSD) for FDA submission Submission & FDA Interaction Compile REMS content in applicable modules of eCTD Submit REMS documents with NDA/BLA or post-marketing supplements Support responses to FDA REMS comments and negotiate final REMS structure REMS Assessment & Modifications Assist sponsors in preparing REMS Assessment Reports Develop REMS modifications or revisions in line with safety updates Monitor and maintain compliance with REMS implementation timelines REMS Integration with Commercial and Safety Operations Coordinate REMS implementation with pharmacovigilance and medical affairs teams Ensure alignment with risk management systems globally (e.g., RMP in EU) Support training of healthcare providers, distributors, and pharmacies as per REMS requirements. Why REMS and ETASU (Elements to Assure Safe Use) Matter These tools allow the FDA and drug manufacturers to protect patient safety while ensuring that necessary medications remain accessible. ETASU can enable the continued marketing of drugs that would otherwise be withdrawn due to risk concerns, by mitigating those risks effectively. Techsol’s Expertise in REMS and ETASU Support At Techsol Life Sciences, we support sponsors in developing and managing REMS programs, including: REMS strategy development and FDA interaction Design and documentation of ETASU components REMS submission in eCTD format Ongoing assessment and reporting support Key Challenges in REMS Evaluating whether a product requires a REMS at submission or post-approval can be difficult. Complex REMS Design: It’s challenging to develop a REMS that meets regulatory expectations without placing an undue burden on stakeholders. Monitoring and Assessment: Collecting, analyzing, and submitting compliance and effectiveness data is often operationally complex and subject to regulatory scrutiny. How Techsol Helps Overcome REMS Challenges At Techsol Life Sciences, we: Conduct REMS feasibility assessments during clinical or pre-approval phases Design REMS programs aligned with FDA guidance and product-specific risk profiles Author REMS documents, implement operational workflows, and manage training tools Support REMS assessments, updates, and ongoing compliance monitoring Facilitate regulatory interactions and strategic communications with the FDA Techsol Expertise Regulatory Expertise: Deep knowledge of REMS regulatory framework and safety labeling requirements ETASU Implementation Guidance: For products requiring

Regulatory Operations Risk Evaluation and Mitigation Strategies (REMS) Plan Our regulatory experts provide end-to-end REMS planning, submission, and maintenance services across the product lifecycle. Request a Consultation At Techsol Life Sciences, we support pharmaceutical and biotech companies in developing and implementing FDA-compliant Risk Evaluation and Mitigation Strategies (REMS) to ensure the safe use of drugs with known or potential serious risks. Our regulatory experts provide end-to-end REMS planning, submission, and maintenance services across the product lifecycle. Risk Evaluation and Mitigation Strategy (REMS) is a regulatory program required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to help ensure that the benefits of the drug outweigh its risks. REMS programs are designed to manage specific risks by reinforcing safe use conditions through communication, training, and monitoring. A REMS may be required during: Initial drug approval Post-market safety evaluation New information on known risks Techsol’s REMS Support Capabilities Techsol has a full range of capabilities and extensive experience supporting REMS programs for clients, including: REMS Needs Assessment Analyze drug safety profile and therapeutic indication Evaluate whether REMS is required per FDA guidance Conduct comparative risk analysis based on similar marketed products REMS Document Preparation Author REMS documents, including goals, elements to assure safe use (ETASU), communication plans, implementation systems, and assessment metrics Prepare REMS Supporting Documents (RSD) for FDA submission Submission & FDA Interaction Compile REMS content in applicable modules of eCTD Submit REMS documents with NDA/BLA or post-marketing supplements Support responses to FDA REMS comments and negotiate final REMS structure REMS Assessment & Modifications Assist sponsors in preparing REMS Assessment Reports Develop REMS modifications or revisions in line with safety updates Monitor and maintain compliance with REMS implementation timelines REMS Integration with Commercial and Safety Operations Coordinate REMS implementation with pharmacovigilance and medical affairs teams Ensure alignment with risk management systems globally (e.g., RMP in EU) Support training of healthcare providers, distributors, and pharmacies as per REMS requirements. Why REMS and ETASU (Elements to Assure Safe Use) Matter These tools allow the FDA and drug manufacturers to protect patient safety while ensuring that necessary medications remain accessible. ETASU can enable the continued marketing of drugs that would otherwise be withdrawn due to risk concerns, by mitigating those risks effectively. Techsol’s Expertise in REMS and ETASU Support At Techsol Life Sciences, we support sponsors in developing and managing REMS programs, including: REMS strategy development and FDA interaction Design and documentation of ETASU components REMS submission in eCTD format Ongoing assessment and reporting support Key Challenges in REMS Evaluating whether a product requires a REMS at submission or post-approval can be difficult. Complex REMS Design: It’s challenging to develop a REMS that meets regulatory expectations without placing an undue burden on stakeholders. Monitoring and Assessment: Collecting, analyzing, and submitting compliance and effectiveness data is often operationally complex and subject to regulatory scrutiny. How Techsol Helps Overcome REMS Challenges At Techsol Life Sciences, we: Conduct REMS feasibility assessments during clinical or pre-approval phases Design REMS programs aligned with FDA guidance and product-specific risk profiles Author REMS documents, implement operational workflows, and manage training tools Support REMS assessments, updates, and ongoing compliance monitoring Facilitate regulatory interactions and strategic communications with the FDA Techsol Expertise Regulatory Expertise: Deep knowledge of REMS regulatory framework and safety labeling requirements ETASU Implementation Guidance: For products requiring Elements to Assure Safe Use (ETASU), we help sponsors develop structured and enforceable ETASU elements, including stakeholder certification processes, restricted distribution programs, and patient monitoring plans. Techsol helps to ensure that your REMS program is FDA-compliant, operationally efficient, and aligned with public health goals. Request a Demo Submit

Regulatory Operations Challenges and Solutions for Labeling Services We provide market-specific guidance and ensure full regulatory compliance for entry into new regions. Request a Consultation Managing global product labeling involves complex challenges due to varied regulatory standards, language requirements, and the need for frequent updates. Here are the key challenges and how Techsol Life Sciences addresses them: Regulatory Compliance Across Markets: Different regulatory requirements in each market can create inconsistencies in labeling. Solution: Techsol ensures compliance with FDA, EMA, ANVISA, and other regional standards, aligning labels while adhering to local regulations. Linguistic and Cultural Accuracy: Translations must be medically accurate and culturally appropriate. Solution: We provide certified translations in over 30 languages, reviewed by native linguists to ensure regulatory and medical accuracy. Label Harmonization: Inconsistent label formats and content across regions can confuse stakeholders. Solution: Techsol ensures harmonized labeling by standardizing content while tailoring it to meet regional requirements.   Tight Submission Deadlines: Meeting tight regulatory submission timelines for updated labels. Solution: With a streamlined workflow, we ensure timely revisions and fast-track processes to meet regulatory deadlines.   Maintaining Consistency in Label Versions: Managing multiple label versions (redline, clean, annotated) can lead to inconsistencies. Solution: Advanced version control and quality checks ensure all versions are aligned and accurate. RLD Comparison: Ensuring your label aligns with the latest Reference Listed Drug (RLD) label. Solution: We use automated comparison tools and expert review to ensure accurate alignment with RLD standards. Local Market Labeling Requirements: Adapting labels for new markets with unique regulatory requirements. Solution: We provide market-specific guidance and ensure full regulatory compliance for entry into new regions. Frequent Label Updates: Managing continuous updates based on new safety data and regulatory changes. Solution: Techsol offers efficient revision processes, ensuring labels are always current and compliant. High-Volume Labeling Demands: Handling large-scale labeling revisions for multiple products and markets. Solution: Techsol’s dedicated teams efficiently manage high-volume updates, ensuring timely delivery without compromising quality. ePI Integration: Ensuring labels comply with electronic product information (ePI) standards. Solution: We integrate ePI formats to ensure compliance with the latest EU ePI guidelines and electronic submission standards. Conclusion: Techsol Life Sciences offers comprehensive solutions to overcome labeling challenges. From regulatory compliance to linguistic accuracy and timely submissions, we streamline the global labeling process, ensuring consistency and efficiency across all markets. Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations Local Labeling and Translation Services: Ensuring Global Regulatory Success Request a Consultation In today’s globalized pharmaceutical market, achieving regulatory compliance goes beyond technical accuracy. It demands linguistic and cultural precision in order to meet the diverse requirements of each country and region. Techsol Life Sciences specializes in local labeling and certified translation services across 80+ languages, ensuring that your product labeling and leaflets are fully compliant with both local regulations and the cultural expectations of patients and healthcare providers. Our local labeling and translation services are designed to help you effectively enter new markets, ensuring patient safety, regulatory compliance, and market readiness. Our Local Labeling and Translation Capabilities Local Language Label and Leaflet Translations We provide high-quality translations for product labels and patient information leaflets (PILs) into over 80 languages. Our team of expert linguists ensures that the translated text conveys the same meaning as the original, while maintaining compliance with local regulatory standards. Medical and Regulatory Accuracy Checks by Native Linguists Every translation undergoes thorough review by native linguists who specialize in medical and regulatory terminology. This ensures the translations are not only linguistically accurate but also meet the stringent medical and regulatory requirements of each country. Label Harmonization Across Regions We help companies harmonize their labels to ensure consistency across regions, making it easier to manage global product labeling and streamline regulatory submissions. This harmonization ensures that your product’s key information is clear and consistent, irrespective of where it is marketed. Compliance with Country-Specific Regulations We stay up-to-date with the latest country-specific regulations and guidelines, including the EU QRD, ANVISA, and TGA standards. Whether it’s the EU’s QRD template, the Brazilian ANVISA requirements, or Australia’s TGA regulations, we ensure your labeling meets the compliance standards for each market. Supported Languages for Local Labeling and Translation Services At Techsol Life Sciences, we support translations in over 80 languages, including but not limited to: English Chinese Hebrew Portuguese Thai Spanish Japanese Polish Indonesian Slovak French Korean Czech Vietnamese Hindi German Arabic Greek Bengali Serbian Italian Turkish Hungarian Tamil Urdu Dutch Russian Romanian Punjabi Ukrainian Our Approach to Local Labeling and Translation Linguistic and Regulatory Precision: We combine the expertise of native linguists and regulatory specialists to ensure all translations meet local legal requirements and are culturally appropriate for your target market. Fast Turnaround: With our efficient process and dedicated linguists, we offer quick translations, enabling you to meet tight regulatory deadlines without sacrificing accuracy. End-to-End Service: From translation to final regulatory submission, we handle everything, including label harmonization, compliance checks, and final approvals, ensuring your product is market-ready. Techsol Life Sciences for Local Labeling and Translation Global Reach with Local Expertise: We understand the importance of local regulations and cultural nuances. Our translation and labeling services are designed to address the unique requirements of each market, ensuring your products meet all compliance standards. Regulatory Compliance: We ensure that all translations and labeling are fully compliant with country-specific guidelines such as EU QRD, ANVISA, TGA, and more, reducing your risk of regulatory rejections and delays. Certified Translators and Linguists: Our team consists of certified medical translators who specialize in pharmaceutical and regulatory content. We prioritize medical accuracy, ensuring that the information is conveyed correctly and clearly. Consistent Quality: We maintain consistent quality across all translations, ensuring your labels and product information remain clear, compliant, and standardized, regardless of market. Time and Cost Efficiency: Techsol offers quick turnaround times for translation services, ensuring that your products can reach the market faster while reducing the overall costs of regulatory compliance. Value proposition Techsol Life Sciences is potential partner for local labeling and certified translation services, offering high-quality translations in over 80 languages to ensure global regulatory compliance. Whether you are entering new markets or updating product information, our comprehensive approach will help you navigate the complexities of local regulations while ensuring accuracy, safety, and efficiency. Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations SmPC (Summary of Product Characteristics) and Electronic Product Information (ePI) for EU Regulatory Compliance Understanding the Importance of SmPC and ePI in EU Regulatory Submissions Request a Consultation Understanding the Importance of SmPC and ePI in EU Regulatory Submissions The Summary of Product Characteristics (SmPC) is a key document in the marketing authorization process for medicinal products in the European Union (EU). It provides detailed, scientifically validated information about the drug, such as its indications, dosage, contraindications, side effects, and more. The SmPC serves as the basis for other regulatory documents, including the Patient Information Leaflet (PIL) and labeling, and it is intended to provide healthcare professionals with essential information for the safe and effective use of the product. At Techsol Life Sciences, we specialize in ensuring that your SmPC and other product information documents comply with the latest EU regulatory requirements and standards. Our approach incorporates the electronic product information (ePI) format to align with the EMA’s digital transition efforts and EU guidelines. SmPC Preparation for EMA Compliance Techsol’s approach to SmPC preparation includes comprehensive support from document creation to submission for EU market authorization. Key SmPC Guidelines and Resources Introduction to SmPC: The SmPC is a core document that outlines essential information about the medicinal product for healthcare professionals, including indications, dosage, side effects, and interactions. It must meet strict regulatory requirements defined by the EMA and aligned with EU Directive 2001/83/EC. Electronic Product Information (ePI): The ePI is part of the EMA’s initiative to digitize product information, enabling easier access to up-to-date drug information. It replaces traditional printed materials with digital formats that can be accessed in real-time. Techsol Life Sciences supports ePI creation and submission, ensuring that your product information is in line with the EU’s digital transformation strategy. EU ePI Common Standard: The EU ePI Common Standard is the technical standard for developing electronic product information for human medicines. It provides guidelines for creating SmPCs and PILs in electronic formats that are compliant with EMA’s requirements. Techsol utilizes this standard to ensure that product information is structured in a way that facilitates its approval and accessibility across all EU member states. Key Principles of ePI for Human Medicines: The ePI system aims to enhance accessibility, consistency, and real-time updates of product information for both healthcare providers and patients. These principles emphasize secure data management, harmonization across member states, and seamless integration with digital platforms. Regulatory Guidelines for ePI in the EU: The EMA guidelines for ePI detail the procedural and technical requirements for electronic submissions, including the use of structured data formats, validation processes, and submission standards. Review of Package Leaflet (PIL): The Package Information Leaflet (PIL) is a critical component of the product information that must be included in the product packaging. The PIL provides patients with essential details about the drug, such as usage instructions, warnings, and potential side effects. Techsol ensures that the PIL complies with both content and regulatory standards. Piloting ePI Creation for EU Medicines: The EMA is piloting ePI systems to improve the accessibility and distribution of product information across the EU. Techsol follows the latest industry practices to implement ePI formats that are compatible with EU regulatory standards and healthcare providers’ needs. Techsol Life Sciences Approach to SmPC and ePI Preparation SmPC Creation and Review: We begin the process of SmPC creation by collecting all necessary clinical and non-clinical data. This information is compiled into the SmPC, with careful attention to detail to meet EMA’s regulatory standards. Our experts review each section, ensuring accurate scientific data, appropriate warnings, dosage instructions, and other necessary information for healthcare professionals. ePI Compliance: Techsol is committed to helping clients transition to ePI. We ensure that the SmPC, PIL, and other product documents are formatted according to the EU ePI common standard, making them compliant with the EMA’s digital and regulatory framework. This enables faster updates, easier access, and seamless integration with the EU’s digital infrastructure. Gap Analysis and Regulatory Alignment: We conduct a thorough gap analysis of existing SmPCs and related product information, ensuring alignment with the latest EMA guidelines. This includes the review of clinical data, regulatory updates, and any other modifications required by the EU regulatory body. ePI Submission and Integration: After the preparation and review of the SmPC and other product documents, we handle the ePI submission process, ensuring that all electronic submissions follow the correct format and submission procedures. Our team manages everything from data validation to final submission to ensure your product information is compliant and up-to-date. Techsol Life Sciences Expertise Expert Regulatory Knowledge: Techsol Life Sciences has a team of regulatory affairs professionals with in-depth knowledge of EU regulations for SmPC and ePI preparation. We stay current with changes in the regulatory landscape to ensure your documents are always compliant. Comprehensive Support: From the creation of SmPC documents to the transition to ePI formats, we offer end-to-end support, ensuring a seamless process that meets all regulatory standards. Electronic Format Expertise: We specialize in ePI preparation, leveraging the EU ePI Common Standard and ensuring compatibility with digital platforms. This enables easier access to updated product information for healthcare professionals and patients. Efficient, Timely Delivery: Techsol’s structured approach to SmPC and ePI preparation ensures timely submission, reducing the time to market for your products. Contact Techsol Life Sciences for SPL Conversion Services If you need expert help with SPL creation, updating, or delisting, Techsol Life Sciences is here to guide you through every step of the process. Our experienced team ensures that your SPLs are fully compliant with FDA, EMA, and other regulatory standards, helping you meet your regulatory goals. Get in touch today to learn how our SPL Conversion Services can support your global regulatory strategy. Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions &

Regulatory Operations QRD Preparation and Guidelines for EMA Compliance Ensuring Compliance with EMA’s Quality Review of Documents (QRD) Guidelines Request a Consultation Ensuring Compliance with EMA’s Quality Review of Documents (QRD) Guidelines The Quality Review of Documents (QRD) is an essential step in the regulatory approval process for pharmaceutical products within the European Union (EU). The QRD ensures that all the product information submitted for medicinal products complies with the EU Directive 2001/83/EC and other relevant regulations. Techsol Life Sciences specializes in QRD preparation, ensuring that the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Labeling are accurate, regulatory-compliant, and aligned with EMA guidelines. QRD Preparation Process for EMA Techsol Life Sciences follows a structured approach to QRD preparation, which involves detailed compliance with EMA guidelines and standards. Our process ensures that all documents adhere to the European Medicines Agency (EMA) regulatory requirements. Key Documents and Templates Used in QRD Preparation Annotated QRD Template The QRD Annotated Template provides a framework for preparing the SmPC, PIL, and labeling documents. It offers guidance on the required content for each section and how to format and structure these documents. This template is essential for ensuring consistency and alignment with EMA guidelines. Directive 2001/83/EC This EU Directive lays down the legal foundation for the marketing authorization of medicinal products for human use, covering essential aspects of the product’s information and labeling. The directive is key to understanding regulatory obligations and the general requirements for the SmPC, PIL, and other documentation. QRD Product Information Template This template is specifically designed for the preparation of product information documents and includes detailed instructions for formatting, content, and submission of the SmPC, PIL, and labeling. It is a crucial document in ensuring the standardization of medicinal product information across the EU. Quality Review Documents for Stylistic Matters The Compilation of Quality Review Documents (QRD) guideline addresses the stylistic aspects of the product information, ensuring that the formatting, language, and tone are consistent and aligned with EU regulations. This guideline helps ensure that the product information is clear, concise, and accessible to healthcare professionals and patients. Summary of Product Characteristics (SmPC) The SmPC is a comprehensive document that provides detailed information about the medicinal product, including its therapeutic indications, contraindications, dosage, and administration. It is used primarily by healthcare professionals to make informed decisions about prescribing the product. The QRD template guides the content and structure of the SmPC, ensuring regulatory compliance. Product Information Templates These templates help ensure that all documents submitted for regulatory approval comply with the EMA’s formatting and content requirements. They ensure clarity and precision in conveying product information to the regulatory authorities. Techsol Life Sciences Approach to QRD Preparation Techsol’s approach to QRD preparation involves meticulous attention to detail and alignment with EMA regulations. Here is an overview of how we manage the QRD process: Document Review and Gap Analysis: We begin by reviewing your existing product information documents (SmPC, PIL, Labeling) and performing a gap analysis to identify any missing or non-compliant content. This analysis ensures that your documents meet EMA’s high standards and regulations. Template-Based Document Drafting: Using the latest QRD annotated templates, we help draft or update your SmPC, PIL, and labeling in line with EMA guidelines. This template-based approach ensures consistency and compliance with EU regulatory requirements. Stylistic and Formatting Compliance: We ensure that your documents comply with the QRD stylistic guidelines, including the appropriate use of headings, bullet points, and terminology. This guarantees that the content is not only accurate but also easily understood by healthcare professionals and patients. Quality Review and Finalization: Once all documents are drafted, we conduct a thorough quality review to check for accuracy, consistency, and regulatory compliance. This final check ensures that all necessary information is included, and the formatting is aligned with the QRD guidelines. Submission Support: After the preparation of SmPC, PIL, and labeling documents, we provide full submission support to EMA or other regional authorities, ensuring that your product information complies with all required guidelines and is ready for approval. Key Benefits of QRD Preparation Services by Techsol Our approach combines in-depth regulatory knowledge, template-driven efficiency, and expert quality checks to deliver accurate and compliant SmPC, PIL, and labeling documents for pharmaceutical products. Regulatory Compliance: Techsol ensures your SmPC, PIL, and labeling documents are meticulously prepared in full alignment with EMA’s QRD guidelines, reducing the risk of regulatory delays or refusals. Streamlined Submission Process: Our template-driven, process-oriented approach enables the efficient preparation of product information documents, ensuring that every submission is clear, complete, and regulator-ready. Timeliness and Accuracy: Leveraging our extensive regulatory experience, Techsol delivers accurate and up-to-date documentation fully compliant with current EU and national regulations, helping sponsors save time and avoid costly rework. Global Expertise: Techsol supports multi-regional submissions to EMA and other global regulatory authorities, ensuring consistent and compliant medicinal product information across international markets. Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations RLD Updates and Labeling Services: Ensuring Compliance and Accuracy At Techsol Life Sciences, we specialize in providing comprehensive RLD update services to ensure your drug labels are always in alignment with the most recent regulatory requirements. Request a Consultation In the world of pharmaceutical and biotech regulations, staying compliant with the latest Reference Listed Drug (RLD) updates is essential for maintaining regulatory integrity. Whether you’re updating for Abbreviated New Drug Applications (ANDA) or other regulatory filings, our team is committed to delivering accurate, timely, and compliant labeling solutions. RLD Update Services Our RLD update services are designed to meet the evolving needs of global pharmaceutical companies, ensuring that product labels are consistently updated in compliance with the FDA, and other regional authority requirements. Our comprehensive service includes: Label Comparison with RLD We provide a side-by-side comparison between your product’s label and the latest approved Reference Listed Drug (RLD) label. This ensures that every modification to the label aligns with current regulatory standards. Redline and Clean Versions Our team produces redline versions that highlight all the modifications (additions, deletions, or edits) made to the label, ensuring full transparency. Additionally, we deliver a clean version of the label, ready for submission or publication. Annotated Patient Information Leaflet (PIL) We annotate the Patient Information Leaflet (PIL), providing context for each label change, such as new safety information, updated dosage instructions, or revised regulatory details. This enhances the clarity and transparency of the updates for both regulatory reviewers and healthcare providers. Compliance Documentation For every update, we provide a detailed compliance report, documenting each change and ensuring it aligns with regulatory guidelines. This includes documenting justifications for any deviations from the RLD, where applicable. Version Control and Audit Trail We maintain a full audit trail of all label revisions, enabling full traceability of changes across multiple versions, ensuring compliance and regulatory clarity. Techsol’s Expertise in RLD Updates At Techsol Life Sciences, we understand the complexities involved in aligning product labeling with ever-changing RLD requirements. Our team of regulatory affairs experts, clinical writers, and compliance professionals brings a wealth of knowledge and experience in managing regulatory labeling requirements across global markets. We specialize in the following areas: Regulatory Strategy and Planning: We work with your team to develop a regulatory strategy that ensures compliance across multiple regions, whether the focus is on the FDA or other international authorities. Standardized Labeling Process: We use a standardized checklist to ensure that all relevant label sections such as active ingredients, safety warnings, indications, and dosage instructions are reviewed and updated accurately. Cross-Regional Expertise: We have a deep understanding of regulatory requirements in various regions, ensuring that your labeling is compliant with local and international standards. Why Choose Techsol for RLD Updates? Regulatory Compliance Expertise: With years of experience in global regulatory affairs, we ensure your labels meet the latest FDA and regional requirements for both initial product launches and ongoing updates. Streamlined and Efficient Process: Our end-to-end process, from redline creation to final clean labels and side-by-side comparisons, is designed for speed and efficiency. We understand the importance of timely submissions and ensure all updates are processed promptly without compromising accuracy. Custom Solutions for Complex Products: We handle both simple and complex products, whether you are working with generic drugs under ANDA or biologics requiring more intricate regulatory documentation. Automated Workflows: We implement automated workflows for side-by-side comparisons, data validation, and document formatting, which reduces manual errors and streamlines the entire process. Transparency and Traceability: Every label update is tracked and documented, providing full transparency and traceability. Our clients can be assured that all modifications are fully compliant and in line with regulatory expectations. Techsol’s Approach to RLD Updates Our approach to RLD updates ensures that all modifications are fully aligned with regulatory requirements and are processed in a way that reduces risk and ensures timely submissions. The steps include: Side-by-Side Comparison with Latest RLD: We meticulously compare your current product label with the latest RLD label to ensure all updates are appropriately documented and aligned with FDA and regional regulatory standards. Detailed Document Versions: Redline Version: This version highlights all changes, providing a clear view of what has been modified, added, or removed from the previous label. Clean Version: This is the final, updated version of the label, free from any mark-up, and ready for final submission. Annotated PIL: We provide context for each change, ensuring that each modification is clear and justifiable. Final Quality Check and Submission: After completing all updates and revisions, we conduct a final quality check to ensure the label meets all regulatory requirements before submitting the final documentation to clients. Ongoing Label Monitoring: As regulations evolve, we continue to monitor changes to the RLD and global guidelines, ensuring that your labeling remains compliant with the latest standards. Benefits of RLD Updates with Techsol Partnering with Techsol Life Sciences for Reference Listed Drug (RLD) updates ensures sponsors achieve the highest levels of accuracy, efficiency, and regulatory confidence. Our expert team meticulously tracks and integrates changes to labeling, safety information, and product characteristics, ensuring that all updates are precise and fully aligned with current health authority expectations. By streamlining the RLD update process, we enhance operational efficiency, reduce the risk of noncompliance, and enable faster decision-making during regulatory submissions. With our global compliance expertise, sponsors can maintain harmonized labeling across regions, mitigate regulatory risks, and ensure seamless alignment with USFDA, EMA, MHRA, Health Canada, and other global authorities. Ready to Update Your RLD Labels? At Techsol Life Sciences, we make RLD updates seamless and compliant, ensuring that your product labels always meet regulatory standards. Whether you are working with ANDA, FDA regulations, we provide the expertise and tools you need for accurate, timely label revisions. Contact us today to discuss how we can assist you with RLD updates and labeling compliance. Let’s ensure your product labeling is always up to date with the latest regulatory standards!!!! Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More

Regulatory Operations Structured Product Labeling (SPL) Conversion Services Our services ensure your product’s labeling is structured, accurate, and fully compliant, whether you’re launching a new product, making safety updates, or managing delisting. Request a Consultation Accurate and Timely SPL Conversions for Regulatory Compliance Across Global Markets Structured Product Labeling (SPL) and other regulatory data conversions require precision and expertise to ensure compliance with regulatory standards. At Techsol Life Sciences, we specialize in providing precise SPL conversions that meet FDA, EMA, and other regional authority requirements. We Support: SPL Creation, Updates, delisting and Validation as per FDA guidelines Electronic Labeling Submissions via the FDA’s Electronic Submissions Gateway (ESG) Conversion of Legacy Data into SPL format Use of tools compliant with HL7 and ICH standards Our SPL Conversion Services Techsol Life Sciences offers end-to-end SPL services to ensure your labeling is compliant with global regulatory standards throughout the product lifecycle—whether creating, updating, or delisting products. SPL Creation & Validation We ensure your SPL is compliant with FDA and HL7 standards, including accurate header data, labeling content, and error-free validation for eCTD submission. SPL Updates We update your SPL to reflect new safety information, clinical data, and regulatory changes, including revised warnings, contraindications, and dosage information. SPL Delisting We manage delisting by updating the product’s status in the FDA database and removing it from public sources like DailyMed. Legacy Data Conversion We convert older labeling formats to the current SPL format, ensuring compliance with FDA and HL7 standards for future regulatory processes. Techsol’s SPL Management Approach Techsol follows a structured process for SPL creation, updates, and delisting, ensuring full compliance and accuracy. Regulatory Strategy: We align SPL submissions with FDA guidelines and PLR requirements. Gap Analysis: Identify missing or incomplete data in headers, drug details, and labeling content. Data Collection: Collaborate with clients to gather up-to-date labeling and safety information. SPL Authoring & Conversion: We create and convert SPL into compliant XML format, including necessary sections like IFUs. Validation & Error Resolution: Validate using FDA tools and resolve any errors to meet HL7 and ICH standards. Final QC Review: Conduct a final review to ensure content accuracy and regulatory compliance. Techsol’s Advantage in SPL Conversion Services Techsol Life Sciences offers a comprehensive and reliable approach to SPL conversion, providing high-quality, compliant, and accurate SPL submissions. We help ensure that your product labeling meets the regulatory requirements of FDA. Key Benefits of Working with Techsol: Regulatory Expertise: Our team is well-versed in FDA SPL guidelines, HL7 standards, and ICH compliance. End-to-End SPL Lifecycle Management: We offer a full range of services from SPL creation and updates to delisting, ensuring your products stay compliant throughout their lifecycle. Accuracy & Compliance: We ensure all SPL submissions are error-free and meet the highest standards of regulatory compliance. Timely Submissions: We can handle urgent submissions, ensuring SPLs are delivered on time even under tight deadlines. Contact Techsol Life Sciences for SPL Conversion Services If you need expert help with SPL creation, updating, or delisting, Techsol Life Sciences is here to guide you through every step of the process. Our experienced team ensures that your SPLs are fully compliant with FDA, EMA, and other regulatory standards, helping you meet your regulatory goals. Get in touch today to learn how our SPL Conversion Services can support your global regulatory strategy. RLD Update Services Our RLD update services are designed to meet the evolving needs of global pharmaceutical companies, ensuring that product labels are consistently updated in compliance with the FDA, and other regional authority requirements. Our comprehensive service includes: Label Comparison with RLD We provide a side-by-side comparison between your product’s label and the latest approved Reference Listed Drug (RLD) label. This ensures that every modification to the label aligns with current regulatory standards. Redline and Clean Versions Our team produces redline versions that highlight all the modifications (additions, deletions, or edits) made to the label, ensuring full transparency. Additionally, we deliver a clean version of the label, ready for submission or publication. Annotated Patient Information Leaflet (PIL) We annotate the Patient Information Leaflet (PIL), providing context for each label change, such as new safety information, updated dosage instructions, or revised regulatory details. This enhances the clarity and transparency of the updates for both regulatory reviewers and healthcare providers. Compliance Documentation For every update, we provide a detailed compliance report, documenting each change and ensuring it aligns with regulatory guidelines. This includes documenting justifications for any deviations from the RLD, where applicable. Version Control and Audit Trail We maintain a full audit trail of all label revisions, enabling full traceability of changes across multiple versions, ensuring compliance and regulatory clarity. Techsol’s Expertise in RLD Updates At Techsol Life Sciences, we understand the complexities involved in aligning product labeling with ever-changing RLD requirements. Our team of regulatory affairs experts, clinical writers, and compliance professionals brings a wealth of knowledge and experience in managing regulatory labeling requirements across global markets. We specialize in the following areas: Regulatory Strategy and Planning: We work with your team to develop a regulatory strategy that ensures compliance across multiple regions, whether the focus is on the FDA or other international authorities. Standardized Labeling Process: We use a standardized checklist to ensure that all relevant label sections such as active ingredients, safety warnings, indications, and dosage instructions are reviewed and updated accurately. Cross-Regional Expertise: We have a deep understanding of regulatory requirements in various regions, ensuring that your labeling is compliant with local and international standards. Why Choose Techsol for RLD Updates? Regulatory Compliance Expertise: With years of experience in global regulatory affairs, we ensure your labels meet the latest FDA and regional requirements for both initial product launches and ongoing updates. Streamlined and Efficient Process: Our end-to-end process, from redline creation to final clean labels and side-by-side comparisons, is designed for speed and efficiency. We understand the importance of timely submissions and ensure all updates are processed promptly without compromising accuracy. Custom Solutions for Complex Products: We handle both simple and complex products, whether you

Regulatory Operations Artwork & Labeling Services Delivering End-to-End Global Labeling Compliance for Life Sciences Products Request a Consultation Delivering End-to-End Global Labeling Compliance for Life Sciences Products In the global life sciences industry, labeling is a critical communication tool that directly impacts patient safety, product usability, market access, and compliance. With constant changes in regulatory expectations and country-specific formatting rules, the challenge for pharmaceutical, biotechnology, and medical device companies lies in maintaining accurate, compliant, and up-to-date product labeling throughout the entire product lifecycle. At Techsol Life Sciences, we offer comprehensive Artwork and Labeling Services designed to help companies manage and maintain compliant labeling and packaging for their global product portfolios. From the initial creation of core labeling documents to region-specific adaptation, artwork generation, regulatory submission support, and lifecycle management, our team ensures your product labeling meets all applicable regulatory, linguistic, and formatting standards. Navigating the Global Labeling Landscape Regulatory authorities such as the FDA (USA), EMA (EU), MHRA (UK), Health Canada, and other agencies have specific and detailed requirements for product labeling, including: Structuring and formatting of prescribing information Patient leaflet readability and linguistic compliance Artwork design elements such as font size, color contrast, barcoding, and serialization Accurate translation of medical and scientific content Timely implementation of safety-related label updates (e.g., black box warnings, contraindications, adverse event information) Inconsistent or non-compliant labeling can result in: Regulatory delays or refusals during approval Product recalls and distribution holds Miscommunication of critical safety or usage information to patients and healthcare providers Techsol bridges the gap between regulatory strategy and operational execution with a labeling team that understands both content and compliance. Our Comprehensive Labeling Services Include: Global Labeling Document Development We support the creation, maintenance, and country-specific adaptation of regulatory labeling documents across all major regions and product types. CCDS (Company Core Data Sheet) Development and ongoing maintenance of global reference labeling to align product information across multiple markets. This includes establishing a harmonized core for safety, efficacy, and dosing information. USPI (U.S. Prescribing Information) Authoring and updating structured product labeling content in accordance with FDA labeling format requirements (PLR/SPL), including Highlights of Prescribing Information, Full Prescribing Information (FPI), and patient information. SmPC (Summary of Product Characteristics) Development of EMA-compliant SmPCs following the latest QRD template, adapted for Centralized, Decentralized, or National Procedures. Instructions for Use (IFU) Creation and formatting of device and combination product IFUs that meet both U.S. and EU expectations under FDA 21 CFR 801 and EU MDR/IVDR, including usability, pictograms, readability testing, and localization. Regulatory-Compliant Artwork Design, Proofreading, and Review We offer full-scope support for the creation, update, and validation of primary and secondary packaging components: Our Capabilities Include Design and layout of packaging elements such as: Cartons, vials, blisters, labels, and leaflets Shippers and overwraps Integration of safety elements like: Tamper-evident seals, unique device identifiers (UDIs), barcodes, and serialization data Dual-proofreading of text and visual content for: Regulatory accuracy Typographical consistency Language correctness (including country-specific translations) Compliance with QRD (EU) and SPL (FDA) standards Tools Used Adobe Creative Suite (Illustrator, InDesign, Acrobat) Global labeling platforms (Veeva Vault RIM, GLAMS, or client systems) Automated and manual proofreading systems Labeling Strategy and Submission Support Our regulatory affairs team works alongside our labeling group to guide clients through global submission requirements involving labeling content and format. Submission Support Includes: FDA Structured Product Labeling (SPL): Creation of XML files Validation using FDA-authorized software Submission via the Electronic Submissions Gateway (ESG) EMA QRD Compliance: Application of the latest EU QRD templates Support for Annexes (Annex I – III) and multilingual labeling Country-specific product information formatting Regulatory Justifications & Lifecycle Submissions: Labeling change justifications for supplements and variations Response documents to health authority queries Supporting documentation for renewals, PBRERs, and PSURs Labeling Lifecycle Management & Change Control Post-approval label changes are common due to evolving safety information, new indications, or regulatory mandates. We offer full lifecycle support to ensure labeling remains current, accurate, and harmonized globally. Lifecycle Labeling Services Include: Impact assessments for label changes across global markets Maintenance of change control records and version tracking Integration of new safety data (e.g., pharmacovigilance-driven updates) Alignment of labeling changes with packaging artwork revisions Support for multi-country implementation of variation submissions (EU Type IB/II, CBE-30, etc.) Our Expertise Deep Regulatory & Operational Expertise Our team comprises regulatory professionals, technical writers, labeling specialists, and graphic designers who bring in-depth knowledge of both science and compliance. This unique blend ensures that your labeling is not only accurate but also regulatory-ready for global submissions. Global Market Readiness We support labeling activities for products being submitted or marketed in: United States (FDA) European Union (EMA, national authorities) Canada (Health Canada) Australia (TGA) Japan (PMDA) Middle East, ASEAN, and Latin American countries Process-Driven, Quality-Assured Services We follow robust SOPs, controlled workflows, and multi-tiered quality checks to ensure that every label and artwork component meets regulatory and internal client standards before approval. Technology-Enabled Delivery We leverage publishing platforms, labeling systems, and collaborative project tools to: Ensure transparency, tracking, and audit-readiness Seamlessly integrate with your existing Regulatory Information Management (RIM) or document management system Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations Regulatory Dossier Gap Analysis Services Comprehensive Gap Analysis to Support Regulatory Compliance Throughout the Product Lifecycle Request a Consultation Getting marketing approval is just the start. Staying compliant with post-approval changes like variations, supplements, and annual reports is essential to keep your product on the market. At Techsol Life Sciences, we provide tailored Gap Analysis Services for post-approval submissions, helping you stay ahead of regulatory changes. From manufacturing updates and safety data to labeling revisions, we ensure your documentation stays accurate and compliant across global markets. Scope of Our Post-Approval Gap Analysis Services Our team evaluates the completeness, regulatory conformance, and technical accuracy of post-approval documentation to ensure readiness for submission across different regulatory pathways: U.S. FDA – Supplements & Annual Reports We conduct gap assessments for: CBER/CDER Supplements (CBE-0, CBE-30, Prior Approval Supplements) Annual Reports for NDAs, BLAs, and ANDAs Gap Review Focus Areas: Verification of change classification per FDA guidance Evaluation of CMC updates, manufacturing site changes, and labeling revisions Review of stability data, batch release testing, and comparability data Assessment of adverse event summaries and PSUR/PBRER alignment Documentation completeness for Form FDA 356h, cover letters, and summary tables EU and Global – Variations & Lifecycle Maintenance For the European Union and other ICH regions, we assess documentation for: Type IA, Type IB, and Type II Variations Work sharing Procedures and Grouped Submissions Renewals and PSUR submissions Gap Review Focus Areas: Correct classification of variation type per EU Variation Regulation (EC No 1234/2008) Conformance with EMA/CMDh procedural templates and timelines Labeling updates and product information (SmPC, PIL, labeling mock-ups) Justifications for quality changes (e.g., manufacturing process, specifications) Assessment of bridging data, prior commitments, and variation history Annual Safety and Performance Updates Gap assessment of Periodic Benefit-Risk Evaluation Reports (PBRERs) Review of PSUR/ASR submissions as per region-specific timelines Evaluation of benefit-risk narrative, new safety signals, and cumulative data analysis Our Approach Document Review: Assessing templates, technical content, and regional formatting Change Impact Assessment: Evaluation of how post-approval changes affect existing product dossiers Compliance Check: Against the latest regulatory guidance (e.g., FDA guidance on post marketing changes, EMA’s Variation Guidelines, WHO TRS for lifecycle management) Readiness Evaluation: For eCTD publishing and submission acceptance Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Gap Analysis for Marketing Authorization Application (MAA) – EU (CP, DCP, MRP, National Procedures) Request a Consultation Expert Gap Analysis to Ensure Regulatory Compliance Across the European Union Navigating the Marketing Authorization Application (MAA) process in the European Union requires strict adherence to complex regulatory frameworks, including EMA guidelines, national authority requirements, and the Common Technical Document (CTD) format. Whether you’re submitting through the Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), or a National Procedure, Techsol Life Sciences provides tailored Gap Analysis Services to ensure your MAA dossiers are complete, compliant, and submission-ready. Our MAA Gap Analysis Approach Covers: Evaluation Across All Application Routes Centralized Procedure (CP): Ensures compliance with EMA/CHMP requirements, including Orphan Designation, Advanced Therapy Medicinal Product (ATMP) status, and centralized SmPC templates. Decentralized (DCP) and Mutual Recognition (MRP) Procedures: Checks dossier consistency across Reference Member State (RMS) and Concerned Member States (CMS), ensuring national variations are adequately addressed. National Procedures: Tailored gap reviews for local authority expectations, including country-specific language requirements and national module templates. Module-by-Module Review (CTD Format) Module 1: Checks for administrative completeness, local forms, declarations (QPPV, GMP), and Annex documents tailored for each EU country. Module 2: Reviews overviews and summaries for scientific accuracy, consistency with full data, and adherence to current EMA guidelines. Module 3: Evaluation of CMC data, including comparability studies, control strategies, validation, and stability testing. Module 4 & 5: Assessment of nonclinical and clinical study data, bridging strategies, statistical analyses, and endpoint justifications. Regulatory Alignment and Compliance Checks Verification of alignment with EMA guidance documents, CMDh best practices, and ICH guidelines (Q8–Q12, M4, M8). Identification of outdated references, missing justifications, and inconsistencies across modules. Country-Specific Requirements Detailed analysis of RMS and CMS-specific documentation preferences (e.g., local labeling formats, PIL readability testing reports, and mock-ups). Assessment of national deviations from EU guidance and procedural expectations. Identification of Gaps and Risk Assessment Detection of missing data, incorrect document structure, or non-compliant formatting. Highlighting potential regulatory objections and suggesting proactive solutions to mitigate delays. Strategic Remediation Planning Development of a targeted plan to close gaps before submission or during the clock-stop period. Support in document updates, additional data generation, and preparation for Scientific Advice or Pre-Submission Meetings. Techsol’s EU MAA Gap Analysis – Fast, Aligned, Submission-Ready Techsol ensures your EU Marketing Authorisation Applications (MAAs) are fully compliant and submission-ready. Our experts identify gaps, align documentation with EMA, CMDh, and national requirements, and support CP, DCP, MRP, and National Procedures. Benefits: Faster approvals with fewer objections Harmonised dossiers across EU Clear requirements, less rework Trusted expertise in multi-country submissions Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Clinical Trial Application (CTA) Gap Analysis Services, Gap Analysis for Marketing Authorization Application (MAA) – EU (CP, DCP, MRP, National Procedures) Request a Consultation Tailored Support for EU, Canada, and Global Regulatory Submissions Understanding the regulatory requirements and documentation standards of each region is crucial when conducting clinical trials across countries. Regulatory gaps or inconsistencies can result in delays, rejections, or extra review cycles. At Techsol Life Sciences, we provide comprehensive Clinical Trial Application (CTA) gap analysis and dossier compilation services. Our regulatory team carefully reviews your existing documentation to identify any missing gaps or non-compliant elements, aligns it with regional requirements, and prepares a fully compliant submission package. Whether you’re targeting the US FDA, EMA, Health Canada, PMDA, or other regulatory authorities, we ensure your clinical trial dossiers are complete, consistent, and submission-ready. EU Clinical Trial Application (CTA) under EU CTR 536/2014 After the implementation of the Clinical Trials Regulation (EU) 536/2014, the European Union has transitioned to a centralized submission system through the Clinical Trials Information System (CTIS), replacing the national submissions under 2001/20/EC. Our approach for EU CTA Gap Analysis: Part I & Part II Document Assessment: Part I (evaluated jointly by all concerned Member States): Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB), Clinical Trial Protocol, and safety data Part II (evaluated nationally): Informed Consent Forms, subject recruitment materials, data protection compliance, and insurance documents CTIS Portal Readiness: Verification of documents for compatibility with CTIS requirements Analysis of data and document versioning Identification of discrepancies between uploaded content and system validation expectations Ethics and Regulatory Synchronization: Ensuring consistency between regulatory and ethics submissions under the new harmonized process GCP and EU Guidance Alignment: Compliance with EMA guidelines, Good Clinical Practice (ICH E6 R2), and EU-specific transparency rules (e.g., layperson summaries, public disclosures) Remediation Recommendations: Actionable strategies to address deficiencies, including missing risk assessments, outdated safety data, or unstructured protocol designs CTA Gap Analysis: Health Canada In Canada, CTAs must adhere to Health Canada’s Food and Drug Regulations and guidance documents, such as GUI-0100 and ICH E6. Health Canada CTA Gap Analysis Covers: Completeness of Form HC/SC 3011 and cover letter Clinical trial protocol and Investigator’s Brochure evaluation Drug Product Summary (DPS) and IMPD structure conformity Evaluation of Product Monograph alignment for marketed drugs used as comparators Readiness for No Objection Letter (NOL) review process and Health Canada reviewer expectations CTA Gap Analysis for Other Global Regions We provide region-specific CTA gap assessments for: United Kingdom (MHRA): Post-Brexit CTA documentation per UK Clinical Trial Regulations; review of Clinical Trial Authorisation (CTA) form, IB, protocol, and UK IRAS alignment Australia (TGA & HREC): Review of CTN/CTX schemes and associated dossier requirements, especially for First-in-Human (FIH) studies Asia-Pacific & LATAM regions: CTA structure and submission readiness checks for countries such as India, China, Brazil, Korea, and South Africa Key Gap Analysis Elements for Global CTAs Include: Alignment with ICH GCP, regional regulations, and template-driven document expectations Verification of investigator details, ethics approvals, informed consent materials, and insurance coverage Ensuring proper justification of dose selection and safety monitoring plans Area of Focus Description Protocol Review Design consistency, inclusion/exclusion criteria, endpoints, safety plan Investigator’s Brochure (IB) Consistency with preclinical/clinical data and product safety profiles IMPD / Product Information Adequacy of CMC, pharmacology, toxicology data across jurisdictions Patient-Facing Documents Gap check of Informed Consent Forms, diaries, and lay summaries Ethics & Regulatory Submissions Readiness for concurrent or sequential review processes Transparency Compliance (EU Only) Review of redaction strategy, public disclosures, and layperson summaries Labeling & Packaging (Investigational) Adequacy of label content, translation needs, and region-specific templates Insurance & Indemnification Docs National conformity and completeness of indemnity documentation Benefits of Techsol’s CTA Gap Analysis Services Accelerates Clinical Trial Authorization: By resolving gaps before submission, we help reduce delays from regulator queries. Region-Specific Precision: Tailored reviews for CTAs across Europe, North America, Asia-Pacific, and emerging regions. Harmonized Documentation: Ensures uniformity across multiple countries for global clinical trial programs. Reduced Regulatory Risk: Lowers the chance of refusals or requests for major modifications. Expert Gap Analysis to Ensure Regulatory Compliance Across the European Union Navigating the Marketing Authorization Application (MAA) process in the European Union requires strict adherence to complex regulatory frameworks, including EMA guidelines, national authority requirements, and the Common Technical Document (CTD) format. Whether you’re submitting through the Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), or a National Procedure, Techsol Life Sciences provides tailored Gap Analysis Services to ensure your MAA dossiers are complete, compliant, and submission-ready. Our MAA Gap Analysis Approach Covers: Evaluation Across All Application Routes Centralized Procedure (CP): Ensures compliance with EMA/CHMP requirements, including Orphan Designation, Advanced Therapy Medicinal Product (ATMP) status, and centralized SmPC templates. Decentralized (DCP) and Mutual Recognition (MRP) Procedures: Checks dossier consistency across Reference Member State (RMS) and Concerned Member States (CMS), ensuring national variations are adequately addressed. National Procedures: Tailored gap reviews for local authority expectations, including country-specific language requirements and national module templates. Module-by-Module Review (CTD Format) Module 1: Checks for administrative completeness, local forms, declarations (QPPV, GMP), and Annex documents tailored for each EU country. Module 2: Reviews overviews and summaries for scientific accuracy, consistency with full data, and adherence to current EMA guidelines. Module 3: Evaluation of CMC data, including comparability studies, control strategies, validation, and stability testing. Module 4 & 5: Assessment of nonclinical and clinical study data, bridging strategies, statistical analyses, and endpoint justifications. Regulatory Alignment and Compliance Checks Verification of alignment with EMA guidance documents, CMDh best practices, and ICH guidelines (Q8–Q12, M4, M8). Identification of outdated references, missing justifications, and inconsistencies across modules. Country-Specific Requirements Detailed analysis of RMS and CMS-specific documentation preferences (e.g., local labeling formats, PIL readability testing reports, and mock-ups). Assessment of national deviations from EU guidance and procedural expectations. Identification of Gaps and Risk Assessment Detection of missing data, incorrect document structure, or non-compliant formatting. Highlighting potential regulatory objections and suggesting proactive solutions to mitigate delays. Strategic Remediation Planning Development of a targeted plan

Regulatory Operations Global Regulatory Dossier Gap Analysis Services Ensuring Regulatory Compliance and Submission Readiness with Confidence Request a Consultation At Techsol Life Sciences, we understand that a well-structured and compliant regulatory dossier is the foundation of successful health authority submissions. With the ever-evolving global regulatory landscape, even the smallest content gaps, inconsistencies, or misalignments can delay product approvals or lead to avoidable deficiency letters. That’s why our Global Regulatory Dossier Gap Analysis Services are designed to provide a meticulous, module-wise evaluation of your submission dossiers ensuring completeness, technical accuracy, and regulatory compliance for global health authority submissions. Whether you’re preparing an Investigational New Drug (IND) application for the U.S. FDA, a New Drug Application (NDA), a Biologics License Application (BLA), an Abbreviated New Drug Application (ANDA), or a Clinical Trial/Marketing Authorization Application (CTA/MAA) for global markets including the EU and Canada, our gap analysis services are tailored to reduce regulatory risk and improve submission readiness. Regulatory Dossier Gap Analysis? A regulatory dossier gap analysis is a systematic review process used to assess the completeness and conformance of the existing technical documentation with the applicable regulatory requirements, standards, ICH guidelines, and market-specific expectations. It allows sponsors to identify data or documentation gaps before submission, reducing the likelihood of rejection or review delays. At Techsol, we take a varied approach to assess both content and format of the dossier and identifying potential deficiencies and offering services or recommendations for remediation. Gap Analysis Services Our team of regulatory professionals performs detailed, submission-type-specific gap analyses across the following application types: Investigational New Drug (IND) – U.S. FDA We review and assess IND dossiers to ensure they are ready for clinical trial initiation in the U.S.: Evaluation of preclinical study summaries, clinical trial protocols, and manufacturing data in Modules 1–5 Review for alignment with FDA guidance, including Pre-IND Meeting Readiness Assessment of investigator brochures (IB), toxicology data, and safety pharmacology Recommendations for missing or inconsistent data to avoid clinical hold issues New Drug Application (NDA) – U.S. FDA For NDA submissions, we provide a comprehensive dossier assessment to ensure: Adequate presentation of CMC, clinical, and nonclinical modules Review of risk management plans (RMPs), REMS, and labeling Evaluation of FDA guidance adherence (e.g., formatting per eCTD specifications) Cross-checking of data integrity between summary documents and full reports Abbreviated New Drug Application (ANDA) – U.S. FDA For generic drug submissions, our analysis focuses on: Bioequivalence study documentation and statistical validation In-vitro dissolution data and product-specific guideline conformity Completeness of DMF references, QbD elements, and excipient justifications GDUFA alignment and module cross-referencing Biologics License Application (BLA) – U.S. FDA Biologic product submissions require in-depth gap assessments: Comparability studies, immunogenicity risk assessments, and analytical method validations Conformance to 21 CFR Part 600 requirements Evaluation of manufacturing processes, quality controls, and biosimilarity data Identification of data that may raise questions during advisory committee or inspection review Key Elements of Our Gap Analysis Approach We conduct an in-depth, multi-layered analysis covering all modules of the eCTD format: 1. Module-wise Review (Modules 1–5) Administrative documents, forms, and regional information (Module 1) Summaries of quality, clinical, and nonclinical data (Module 2) Chemistry, Manufacturing, and Controls (CMC) data (Module 3) Nonclinical pharmacology/toxicology and safety studies (Module 4) Clinical study reports, trial data, statistical analyses (Module 5) 2. Regulatory Conformance Check Assessment against current FDA, EMA, Health Canada, PMDA, TGA, and WHO requirements Identification of outdated formats, obsolete guidance references, or inconsistent documentation 3. ICH and Regional Guidelines Alignment Ensuring compliance with ICH M4, M8 (eCTD), and Q8–Q12 series for quality risk management, development, and lifecycle considerations 4. Deficiency Risk Assessment Detection of incomplete or poorly justified data Identification of gaps that could trigger a major objection or query from regulatory reviewers 5. Remediation Planning Customized strategies to fill identified gaps Recommendations on data generation, justification letters, bridging strategies, or scientific advice meetings Advantages of Selecting Techsol’s Services for Gap Analysis Faster Submission Readiness: Sponsors can proactively address issues, accelerating the regulatory timeline. Minimized Regulatory Risk: Reduced chance of receiving Refuse-to-File (RTF) letters, 483s, or deficiency queries. Global Harmonization: Ensures consistent content across submissions to multiple markets. Supports Lifecycle Management: Facilitates smooth variations, renewals, and post-approval changes. Strategic Planning: Allows for prioritization of critical data generation and informed decision-making for go/no-go milestones. Value proposition Multidisciplinary Expertise: Regulatory, clinical, and publishing experts with experience across product types. Global Market Knowledge: Proven submissions in FDA, EMA, PMDA, TGA, Health Canada, and key global regions. Technology-Driven Processes: Validated tools for eCTD, NeeS, ACTD, and regional portal compliance. End-to-End Support: From gap analysis to submission and lifecycle management. Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Health Authorities Submission Gateways (FDA ESG, EMA CESP, PMDA gateway, etc.) Request a Consultation At Techsol Life Sciences, we ensure seamless delivery of regulatory dossiers to global health authorities through their respective electronic submission gateways with extensive experience in handling country-specific portal requirements, we manage the end-to-end submission process from final validation to successful upload and acknowledgment tracking. What Sets Our eCTD Submission Services Apart? Country-Specific Regulatory Compliance We ensure each eCTD submission is designed according to the latest agency-specific guidelines, templates, and requirements. This includes: FDA (United States): We manage IND, NDA, ANDA, and BLA submissions through the ESG portal, guaranteeing metadata accuracy, gateway envelope compliance, and proactive tracking of acknowledgment sequences (ACK 1, 2, and 3). EMA and EU Member States: We facilitate MAA and variation filings via CESP under CP, DCP, MRP, or national routes. Health Canada: We handle NDS, ANDS, CTA, SNDS, and NC filings via the Canadian ESG system. PMDA (Japan): We expertly manage the Japanese eCTD format, including gateway configuration and lifecycle sequences. TGA (Australia) and HSA (Singapore): We provide support for regional submissions in their evolving digital formats. Secure Upload of Submission Our trained submission coordinators: Log into the appropriate portal Upload the validated submission package Complete required metadata fields and attach necessary cover letters or forms Confirm successful file transmission Acknowledgment (ACK) Tracking After submission: We monitor all system-generated acknowledgments (e.g., ACK 1, 2, and 3 from FDA ESG) Track submission acceptance or errors from the authority’s end Resolve any rejections or warnings promptly All acknowledgment documents are archived and shared with the client for reference and audit readiness. Archival and Documentation We securely store: Final submission package Validation reports Gateway upload confirmations and ACKs Why Clients Choose Techsol Life Sciences Global Experience: Submissions across the US, EU, Canada, Japan, Australia, and Asia Dedicated Submission Teams: Trained professionals handling gateway uploads, ACK tracking, and query responses Regulatory Accuracy: No compromise on document quality, formatting, and lifecycle tracking Speed and Reliability: Accelerated timelines without sacrificing compliance Challenges in Regulatory eCTD Services Document Structure and Content Management: Ensuring consistent CTD structure, metadata tagging, and document granularity across large volumes of documents can be time-consuming and error-prone. Technical Errors in Submission: Each regulatory authority has specific validation tools and rules, making technical compliance a moving target. Using Electronic Gateways: Successfully submitting through gateways like FDA ESG, EMA CESP, PMDA Gateway requires deep familiarity with: Access credentials File packaging formats Acknowledgment interpretation and issue resolution Tight Deadlines: Regulatory submissions are often time-sensitive, and meeting deadlines without errors requires a skilled team and efficient tools. Techsol’s Regulatory Publishing Value Proposition At Techsol Life Sciences, we deliver end-to-end regulatory publishing solutions that ensure accurate, compliant, and timely submissions to global health authorities. Our expert regulatory publishers guarantee precise eCTD formatting and consistency, leveraging in-depth knowledge of regional specifications including FDA, EMA, PMDA, and other global agencies. By utilizing industry-standard validation tools such as Lorenz Validator. We ensure error-free sequences and on-time submissions that drive successful approvals. Additionally, Techsol provides complete electronic gateway management, including setup, secure file uploads, and acknowledgment tracking, ensuring a seamless and reliable submission process from start to finish. Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Compilation and validation using global publishing tools (e.g., Lorenz, Veeva RIMS) Request a Consultation At Techsol Life Sciences, we understand that successful regulatory submissions begin with robust eCTD validation. Each health authority has its own set of validation rules, technical requirements, and region-specific compliance standards. Our specialized eCTD validation services ensure that your dossiers are error-free, technically sound, and submission-ready. Key Capabilities: Comprehensive Document Compilation Conversion of source documents to submission-ready formats (PDF compliance, TOCs, bookmarks, hyperlinks) eCTD module compilation and document granularity alignment Integration of study data (SAS outputs, datasets, CRFs) and trial information into eCTD structure Publishing Tool Expertise Our team is experienced in global publishing platforms, including: Lorenz docuBridge Veeva Vault RIMS EXTEDO eCTD manager What We Do in Validation of eCTD Sequences: Our expert publishing team performs thorough validation of eCTD sequences using industry-recognized tools to check for: XML backbone structure issues Document granularity and placement errors Broken hyperlinks and bookmarks Incorrect metadata and regional tagging’s Sequence lifecycle and submission context consistency Error Rectification & Revalidation If validation errors are identified, our team: Diagnoses root causes of technical failures Rectifies issues in document placement, file naming, sequence structure, or metadata Performs re-validation until all errors and warnings are cleared eCTD Validation and Compliance Validation of sequences against region-specific standards (e.g., US FDA, EMA, Health Canada, PMDA) Use of Lorenz eValidator and other validation tools to detect technical errors before final submission Generating and reviewing validation reports to ensure readiness Audit-Ready Documentation Complete tracking and version control of published sequences Generation of publishing logs and validation reports for QA and archival Why Choose Techsol? Skilled team with hands-on experience across multiple publishing platforms Accelerated publishing timelines with quality-controlled outputs Proactive error resolution through advanced validation checks Support for initial submissions, lifecycle updates, and global rollouts Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Lifecycle management and submission updates (amendments, supplements, variations) Request a Consultation At Techsol Life Sciences, we recognize that regulatory submissions do not end with initial approvals. Our Regulatory Lifecycle Management services ensure continuous compliance and timely updates throughout the product’s life cycle. We provide complete support for submission updates, including amendments, supplements, variations, and other post-approval changes to maintain the regulatory health of your product in global markets. Our Lifecycle Management Services Include: Submission Updates and Maintenance Preparation and publishing of: Amendments (e.g., protocol changes, clinical trial updates) Supplements (e.g., labeling changes, CMC updates) Variations (Type IA, IB, II for EU MAA, SmPC updates, administrative changes) Annual reports, PSURs, and renewals Global Change Management Coordinated support for product changes across multiple markets with regulatory impact assessments and aligned submission strategies. Impact Analysis & Regulatory Strategy Assessing regulatory impact of changes (e.g., manufacturing site changes, packaging updates, formulation modifications) and advising on appropriate submission pathways. Timely Compilation and Publishing Publishing submission updates in eCTD/NeeS/paper formats in compliance with region-specific guidelines (FDA, EMA, Health Canada, TGA, etc.). Version Control & Documentation Tracking Use of validated systems for document versioning, sequence tracking, and correspondence archiving to ensure traceability and audit readiness. Agency Interactions Managing communications and queries from regulatory authorities related to post-approval submissions. Value proposition Expertise in managing complex multi-region post-approval submissions Strong knowledge of country-specific variation regulations Streamlined publishing processes to reduce turnaround time Full lifecycle visibility and document traceability Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Operations eCTD Publishing and Submission Services Preparation and publishing of regulatory dossiers in eCTD, NeeS, and paper formats Request a Consultation At Techsol Life Sciences, we specialize in the preparation of country-specific regulatory dossiers, ensuring full alignment with the latest health authority specifications and evolving global regulatory guidelines. Our comprehensive eCTD preparation and publishing services are designed to meet the submission requirements of major markets worldwide. With deep domain expertise across diverse regulatory frameworks, we support pharmaceutical and biotech companies in the preparation, compilation, publishing, and submission of high-quality dossiers in eCTD, NeeS, and paper formats. Our Expertise Our regulatory experts stay up to date with evolving agency expectations across major markets such as the USA (FDA), Europe (EMA), Canada (Health Canada), Japan (PMDA), Australia (TGA), Singapore (HSA), and other emerging regions. By combining regulatory precision with technical excellence, Techsol ensures every submission is accurate, compliant, and globally accepted. Our Capabilities Include: Dossier Preparation Preparing a regulatory dossier involves compiling all required scientific, clinical, and administrative documentation to support a drug or biologic application for marketing authorization or clinical trial approval with a health authority (e.g., FDA, EMA, Health Canada). Our team is highly experienced in assembling dossiers for a wide range of application types, including IND, NDA, ANDA, BLA, CTA, and MAA, tailored to the specifications of global agencies such as the FDA, EMA, Health Canada, MHRA, and others. Techsol’s Regulatory Dossier preparation services include: Strategic document planning and content placement across eCTD modules Formatting and structuring of documents as per agency guidelines Conversion of documents into agency-compliant formats (PDF, XML backbone) Hyperlinking, bookmarking, and Table of Contents generation Preparation of metadata and submission-ready packages Support for both initial and lifecycle submissions We specialize in preparing high-quality documents across all modules of the Common Technical Document (CTD/eCTD) format, including: Module 1: Regional Administrative and Product Information Module 2: Summaries and Overviews Module 3: Quality (CMC) Documentation Module 4: Nonclinical Study Reports Module 5: Clinical Study Reports eCTD Publishing by Techsol: As part of our end-to-end eCTD Publishing Services, Techsol Life Sciences ensures all documents meet stringent PDF specifications required by global regulatory authorities. Proper formatting of PDFs is critical for submission acceptance, navigation, validation, and review by agencies like the FDA, EMA, Health Canada, and others. Publishing Tools and Platforms We are Skilled in using industry-standard publishing tools such as EXTEDO eCTD manager, Lorenz docuBridge. and follow strict quality control processes to deliver error-free, submission-ready eCTD sequences, helping you achieve faster approvals and regulatory compliance. Key PDF Compliance Activities Include: File Version and Format Standardization All documents are converted to PDF 1.4 or 1.7 (as required) to ensure compatibility with agency review tools and validation software. Optimized File Size and Resolution Images, scans, and embedded content are optimized to maintain clarity while reducing file size, enhancing upload speed and system performance. Document Navigation Include bookmarks and a hyperlinked Table of Contents for documents longer than five pages. Use relative paths for hyperlinks. Hyperlinks should open in a new window Use “Inherit Zoom” for destination view Fonts and Text Accessibility All fonts are embedded, and text is searchable/selectable, allowing agency reviewers to easily annotate and extract information. Security and Accessibility Settings Documents are free from encryption, password protection, and editing restrictions, meeting regulatory expectations for open document review. Fast Web View Enabled PDFs are saved with Fast Web View enabled, allowing faster rendering during online review by agency assessors. Consistent Headers, Footers, and Pagination Each file adheres to submission unit requirements with consistent naming, pagination, and standardized headers/footers. At Techsol Life Sciences, we utilize advanced publishing tools and follow global regulatory guidelines to ensure that every document submitted is technically compliant and review-ready. Our meticulous approach to PDF property management minimizes the risk of validation errors and enhances overall submission quality. Techsol has deep regional expertise in North America (USA and Canada) and Europe and other countries. Techsol provides end-to-end support for eCTD publishing, NeeS, and paper-based submissions. Value proposition Techsol adopts a highly structured and thorough process for managing PDF properties in line with regulatory standards. Deep understanding of regional submission requirements Rapid turnaround with strict adherence to regulatory timelines Seamless integration with your internal teams and systems Proven track record of successful global submissions Regulatory Operations Services eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More SmPC & ePI Read More Local Labeling & Translations Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Request a Demo Submit

Regulatory Affairs Pre-BLA Meetings Whether you’re submitting a traditional biologic, a novel gene therapy, or participating in an expedited review program, Techsol ensures your Pre-BLA meeting is focused, well-documented, and strategically aligned with FDA’s expectations. Request a Consultation Accelerate Biologic Approvals with Techsol’s Pre-BLA Meeting Expertise Pre-BLA Meetings – Overview At Techsol Life Sciences, we support biopharma innovators in planning and executing Pre-BLA (Biologics License Application) meetings that pave the way for regulatory success. These critical Type B meetings with the U.S. FDA are designed to confirm the adequacy of your data, the structure of your submission, and any remaining concerns prior to filing a BLA. Pre-BLA Meeting A Pre-BLA (Biologics License Application) Meeting is a Type B formal interaction between a sponsor and the U.S. FDA held prior to the submission of a BLA. It serves as a critical regulatory checkpoint where sponsors confirm the completeness, quality, and format of their application and address any remaining agency concerns. At Techsol Life Sciences, we guide sponsors through Pre-BLA preparations with strategic, technical, and documentation support to de-risk the submission, clarify FDA expectations, and accelerate regulatory review timelines—especially for complex products like biologics and gene therapies. Scope of a Pre-BLA Meeting The Pre-BLA meeting focuses on ensuring that the sponsor’s final submission package aligns with FDA requirements. Its scope includes: Verification of Application Completeness: Confirming that all required data (CMC, clinical, safety) will be included Discussion of Clinical Efficacy & Safety Results: Key findings, pivotal trial data, and safety profiles Review of CMC Data: Manufacturing processes, comparability, analytical validation, and product release testing Labeling Strategy & Content Plan: USPI, prescribing information, REMS (if applicable), and carton/container labeling Electronic Submission Format: eCTD readiness, structure, and technical file validation Post-Marketing Requirements: Plans for pharmacovigilance, risk mitigation, and post-approval commitments Expedited Program Considerations: Eligibility or ongoing designation under Fast Track, Priority Review, Breakthrough Therapy, etc. Key Elements of a Pre-BLA Meeting Strategic Planning & Gap Assessment Identification of submission readiness status and regulatory gaps Review of development timeline, fast-track status, and review designation eligibility Meeting Request Submission Preparation and formal submission of a Pre-BLA meeting request to CDER or CBER, depending on product type Briefing Package Development Authoring a CTD-formatted briefing package, including: Overview of product, indication, and development history Summaries of pivotal clinical trials, safety data, and CMC readiness Specific questions for FDA review and clarification Targeted Question Strategy Prioritized queries related to: Data sufficiency Labeling expectations Post-marketing study requirements Submission format or missing modules Meeting Logistics & Coordination Coordination of teleconference or face-to-face meeting Cross-functional team alignment (Regulatory, Clinical, Safety, CMC) Meeting Execution Support Preparing internal stakeholders with speaker scripts and response plans Capturing notes and clarifications during the FDA interaction Post-Meeting Follow-Up Consolidating FDA feedback and meeting minutes Developing an action plan to address feedback before final BLA submission Updating submission timeline, format, and content as needed How Techsol Enables Pre-BLA Meeting Success A well-executed Pre-BLA meeting can significantly streamline your submission process and avoid last-minute regulatory challenges. Techsol supports the full meeting lifecycle: Pre-Meeting Strategy & Risk Identification – Early planning and data readiness assessments to ensure your development program is aligned for BLA submission. Meeting Request Management – Submission of formal meeting requests to CDER or CBER, with correct categorization and timelines. Briefing Book Development – Preparation of high-quality, CTD-formatted briefing packages addressing clinical, CMC, safety, labeling, and post-marketing topics. Targeted Question Development – Framing of strategic questions to confirm submission completeness, formatting alignment, and regulatory expectations. Meeting Logistics Coordination – Scheduling and managing FDA teleconferences, face-to-face discussions, or written responses. Post-Meeting Documentation & Follow-Up – Capturing formal meeting minutes, aligning submission plans with FDA guidance, and managing follow-up actions. Value proposition Proven Experience with Complex Biologics & Gene Therapies – We support advanced product submissions requiring in-depth FDA dialogue and clarification. Integrated Regulatory, CMC & Clinical Expertise – Our team brings a 360° view of BLA data requirements to deliver complete and compelling briefing content. Accelerated Submission Readiness – We identify and address potential roadblocks early—streamlining your timeline to filing and review. Strategic FDA Alignment – Our experts ensure your submission format, content, and timeline align with FDA feedback to reduce the risk of review delays. Expedited Program Insight – Support for programs under Fast Track, Priority Review, RMAT, or Orphan Drug Designation to maximize review advantages. Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Request a Demo Submit

Regulatory Affairs Pre-NDA Meetings Request a Consultation Pre-NDA Meeting A Pre-NDA (New Drug Application) Meeting is a formal, Type B interaction between a sponsor and the U.S. FDA, typically held prior to submitting an NDA. This meeting provides an opportunity for sponsors to obtain FDA feedback on the overall data package, regulatory strategy, and submission readiness to support marketing approval. Scope of Pre-NDA Meeting The scope of a Pre-NDA meeting includes alignment on late-stage development outcomes, regulatory expectations, and submission details across the following areas: Clinical Data Review: Discussion of pivotal trial results, safety and efficacy endpoints, and statistical analysis plans CMC and Quality: Review of drug substance and drug product manufacturing, stability, and control strategies ensuring compliance with regulatory standards Labeling Strategy: Early input on proposed product labeling, claims, and risk mitigation plans Regulatory Pathway: Confirmation of submission format, expedited programs (e.g., Priority Review, Fast Track), and post-approval commitments FDA Feedback on Potential Gaps: Identification of deficiencies that could delay filing acceptance or approval Submission Format and Content Expectations: Guidance on eCTD structure, module completeness, and data presentation Key Elements of a Pre-NDA Meeting Strategic Planning & Gap Assessment Internal reviews to assess pivotal data readiness and regulatory compliance Regulatory intelligence gathering on FDA expectations and precedent cases Meeting Request Submission Formal submission of the meeting request to the relevant FDA review division via the CDER or CBER NextGen Portal Briefing Package Development Authoring a comprehensive Pre-NDA briefing package in CTD format, including: Product overview and clinical development summary Summaries of clinical efficacy, safety, and CMC data Specific, targeted questions for FDA feedback Question Strategy & Risk Prioritization Developing clear and focused questions to clarify FDA expectations and reduce uncertainty Organizing questions by clinical, CMC, labeling, and regulatory topics for efficient discussion Meeting Logistics & Coordination Scheduling and coordinating teleconference, written response, or in-person meetings Ensuring participation of key cross-functional stakeholders Meeting Execution Support Preparing speaker notes and conducting internal rehearsals Managing real-time FDA interactions and note-taking Post-Meeting Documentation & Action Plan Consolidating meeting minutes and analyzing FDA feedback Incorporating feedback into final NDA submission plans and timelines How Techsol Enables Pre-NDA Meeting Success Techsol Life Sciences delivers end-to-end support to maximize the value of Pre-NDA meetings: Regulatory Intelligence & Gap Analysis – Evaluating clinical and CMC data readiness, identifying risks that may impact NDA acceptance or approval timelines Briefing Package Development – Crafting detailed, FDA-compliant briefing books in CTD format with clear presentation of clinical and quality data Question Strategy – Formulating targeted questions to obtain critical FDA guidance on pivotal trials, labeling, manufacturing, and regulatory pathways Meeting Logistics Management – Handling meeting request submissions and scheduling via FDA portals, tracking progress, and managing deadlines Sponsor Preparation & Meeting Readiness – Providing thorough pre-meeting coaching, role-play Q&A, and strategic alignment for successful FDA interactions Post-Meeting Follow-Up – Delivering concise meeting summaries, interpreting FDA feedback, and developing actionable plans for timely NDA submission Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: BLA Read More Request a Demo Submit

Regulatory Affairs Pre-Submission Meeting We assist in Pre-NDA meetings by reviewing pivotal trial data packages and submission plans to meet FDA expectations on efficacy, safety, and labeling. For biologics, we provide comprehensive support for Pre-BLA meetings, addressing clinical, manufacturing, and regulatory requirements critical to successful Biologics License Application filings. Request a Consultation Overview At Techsol Life Sciences, we possess extensive experience supporting clients in preparing and managing Pre-IND, Pre-NDA, and Pre-BLA meetings with the FDA to ensure efficient drug development and regulatory approval. Our expertise includes guiding sponsors through early Pre-IND meetings to align nonclinical, CMC, and clinical strategies, thereby minimizing the risk of clinical holds. Pre-IND Meeting A Pre-IND (Investigational New Drug) Meeting is a formal, Type B interaction between a sponsor and the U.S. FDA, typically held before submitting the first IND application. This meeting allows sponsors to obtain early regulatory guidance on their nonclinical, clinical, and CMC (Chemistry, Manufacturing, and Controls) plans. Scope of Pre-IND Meeting The scope of a Pre-IND meeting encompasses early-stage regulatory strategy, development plan validation, and FDA engagement across the following areas: Clinical Development Plans: Discussion of first-in-human trial design, endpoints, patient population, and dose selection Nonclinical Data Requirements: Assessment of toxicology studies, pharmacology plans, and bridging data CMC Readiness: Review of manufacturing controls, analytical methods, stability data, and comparability strategy Regulatory Pathway Clarification: Confirming the appropriate IND pathway and any expedited designations (e.g., Fast Track, Orphan Drug) FDA Feedback on Gaps or Risks: Early identification of issues that could delay IND acceptance or trial initiation Clarification of Submission Format and Expectations: Including eCTD structure, module organization, and content completeness Key Elements of a Pre-IND Meeting Strategic Planning & Gap Assessment Internal readiness reviews to identify development gaps and prioritize discussion points Regulatory intelligence gathering based on precedents, FDA guidance, and product class Meeting Request Submission Formal submission of a meeting request to the appropriate FDA review division via the CDER or CBER NextGen Portal Briefing Package Development Authoring a well-structured Pre-IND briefing package (in CTD format) including: Product overview and development rationale Summaries of CMC, nonclinical, and clinical data Specific, targeted questions for FDA feedback Question Strategy & Risk Prioritization Framing of clear, concise questions to clarify regulatory expectations and minimize ambiguity Grouping questions by topic (CMC, nonclinical, clinical) for structured discussion Meeting Logistics & Coordination Scheduling the meeting (teleconference or written response only) Ensuring participation from key cross-functional stakeholders Meeting Execution Support Preparing speaker notes, internal rehearsals, and managing FDA discussions Real-time note-taking and clarification during the meeting Post-Meeting Documentation & Action Plan Consolidating meeting minutes Analyzing FDA feedback and incorporating it into the development strategy Establishing timelines and deliverables for IND submission How Techsol Enables Pre-IND Meeting Success We approach each Pre-IND meeting as a key regulatory milestone that can drive smarter, faster development decisions. Our support includes: Regulatory Intelligence & Gap Analysis – Assessment of development plans and identification of risks and gaps in your clinical, nonclinical, and CMC strategies. Briefing Package Development – High-quality authoring of FDA-compliant briefing books in CTD format, including background, study plans, and rationale. Question Strategy – Targeted question development to obtain FDA feedback on trial design, safety studies, manufacturing controls, and regulatory classification. Meeting Logistics Management – Complete coordination of the meeting request and timelines via FDA’s CDER NextGen Portal, with Type B meeting tracking. Sponsor Preparation & Meeting Readiness – Support for teleconferences, written responses, or face-to-face meetings with role-play Q&A and strategy alignment. Post-Meeting Follow-Up – Consolidation of meeting minutes, interpretation of FDA feedback, and development of a strategic action plan for IND readiness. Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Request a Demo Submit

Regulatory Affairs Gene therapy Products Regulatory Services We provide comprehensive regulatory support for gene therapy products, guiding sponsors through every stage of development — from preclinical studies to marketing authorization and post-approval compliance. Request a Consultation Overview Gene therapies represent a rapidly evolving area of healthcare with unique scientific, technical, and regulatory complexities. Successful development and approval of these advanced therapies require specialized expertise to navigate stringent global regulatory frameworks. At Techsol, we provide comprehensive regulatory support for gene therapy products, guiding sponsors through every stage of development — from preclinical studies to marketing authorization and post-approval compliance. Our Expertise Strategic Regulatory Planning Key Services: Early Regulatory Intelligence Evaluation of current FDA and EMA guidelines for gene therapy (e.g., CBER Guidance, EMA ATMP regulations). Gap analysis for preclinical and clinical development readiness. Product Classification & Regulatory Pathway Assessment US: IND → BLA (CBER/OTAT, now Office of Therapeutic Products – OTP). EU: ATMP classification, CAT (Committee for Advanced Therapies) evaluation, MAA. Regulatory Roadmap Development Defining timelines, submission strategy, and interaction plan with FDA & EMA. Orphan designation, RMAT (US) / PRIME (EU) pathway evaluation. Pre-IND / Scientific Advice & Regulatory Interactions US FDA: Pre-IND meetings with CBER/OTP. RMAT designation request and guidance alignment. EU: ATMP classification request to EMA. Scientific Advice / PRIME eligibility request. Early dialogue with CAT & CHMP for development alignment. Techsol Support Includes: Meeting request preparation, briefing package authoring, and Q&A strategy. Representation during meetings and managing regulatory follow-ups. Nonclinical (Pre-Clinical) Regulatory Support Activities: Study Planning & Report Authoring: GLP-compliant safety, biodistribution, shedding, and tumorigenicity studies. Immunogenicity and germline transmission studies for viral vector-based therapies. Document Preparation: US: Nonclinical sections of IND & BLA Module 4 (CTD). EU: Nonclinical Summaries, Overviews, and Environmental Risk Assessments for MAA. Techsol Expertise: Template-based writing, QC, SME review, and alignment with latest FDA/EMA expectations. Clinical Development Regulatory Support Key Deliverables US FDA: IND preparation, amendments, and annual reports. EU: CTA submission, protocol assistance, IMPD preparation, and DSURs. Ongoing Compliance Safety reporting (SAE/SUSAR), patient follow-up requirements, and long-term follow-up plans for gene therapy trials. Techsol Approach Submission-ready CTD authoring, regulatory QC, and RIM (Regulatory Information Management) support. CMC / Manufacturing Regulatory Services Gene Therapy-Specific CMC Support: Vector characterization, potency assays, and comparability studies. Process validation and viral clearance studies. Submission Documentation: IND/BLA Module 3 (CMC) preparation for US. IMPD / MAA Quality Module for EU. Regulatory Interactions: FDA Type C meetings or EMA Quality & ATMP CMC consultation for complex issues. Marketing Authorization & Post-Approval Lifecycle Management US: BLA Submission & Review Management eCTD compilation, RTF readiness, and FDA query management. Labeling negotiations with CBER. Post-Approval Compliance: Annual reports, post-marketing commitments (PMCs/PMRs), long-term follow-up (LTR), REMS (if applicable). EU: MAA Submission & CHMP/CAT Interactions Dossier preparation, eCTD submission, RFI/LoQ management. Post-Approval PSUR/PBRER, risk management plan (RMP) updates, post-authorization safety studies (PASS), variations & renewals. Additional Specialized Services for Gene Therapy Orphan Drug Designation and Maintenance. RMAT / Breakthrough / PRIME expedited pathways. Environmental Risk Assessment (ERA) for EU. Long-term follow-up (LTR) study planning for integrating safety over 15 years. Advisory on new guidance updates (e.g., FDA Human Gene Therapy CMC, Clinical & Long-term Follow-up Guidance). Capabilities & Value Proposition Dedicated Gene Therapy Experts with in-depth knowledge of ATMP guidelines Global Regulatory Experience across US, EU, Japan, and emerging markets. Proven Track Record in handling complex CMC and clinical challenges. Cross Functional Collaboration with nonclinical, clinical, and manufacturing teams. Request a Demo Submit

Regulatory Affairs HA interactions & local country support With deep experience supporting USFDA pathways, we manage the planning, authoring, and execution of key meetings including Pre-IND, End-of-Phase, Pre-NDA/BLA, and Type A/B/C interactions. Request a Consultation Overview At Techsol Life Sciences, we help clients build strategic, compliant, and confident relationships with global health authorities (HAs). From early development through post-approval stages, our regulatory team supports structured agency interactions that enhance submission clarity, reduce regulatory risk, and improve the speed of decision-making. Beyond the U.S., Techsol delivers localized regulatory support across the EU (EMA and National Agencies), UK (MHRA), Canada (Health Canada), Australia (TGA), Japan (PMDA), and other major markets in LATAM, APAC, and MENA. We work with local affiliates or partners to adapt global dossiers, manage country-specific formatting, and ensure timely submissions with regionally compliant content. Health Authority Interactions & Local Country Support Health Authority (HA) Interactions & Local Country Support refer to the strategic and operational activities that enable effective communication with global regulatory agencies and support country-specific regulatory requirements for successful product development and approvals. At Techsol Life Sciences, this service ensures that sponsors are well-prepared for regulatory interactions (e.g., Pre-IND, End-of-Phase, Pre-BLA meetings) and maintain compliance with local regulatory procedures across global markets. We bridge centralized strategy with on-the-ground execution, enabling efficient and compliant submissions across diverse geographies. Scope of Global HA Interactions Support Techsol’s services in Health Authority (HA) interactions and local country support extend from early-stage development through post-approval, combining global regulatory coordination with region-specific operational execution: Regulatory Agency Meeting Support Engagement with USFDA (Pre-IND, EOP, Pre-NDA/BLA, Type A/B/C), EMA (Scientific Advice), PMDA (Consultations), and other global authorities Briefing Package Development & Strategy Authoring of targeted briefing documents, strategic question framing, and scientific justifications Meeting Logistics Management Submission of meeting requests, scheduling, and coordination of teleconferences or in-person meetings Regulatory Correspondence & Response Handling Timely preparation of responses to agency queries and tracking of post-meeting commitments In-Country Regulatory Support Local dossier formatting, submission logistics, and regulatory engagement via regional affiliates or partners Multilingual Translation & Document Localization Certified translations of core regulatory documents, safety reports, and labeling content for compliance with local language requirements Market-Specific Intelligence & Procedural Guidance Strategic support for product registration and lifecycle submissions across the U.S., EU, Canada, LATAM, APAC, MENA, and other markets Key Elements of HA Interactions & Local Country Support Strategic Meeting Planning & HA Communication Defining clear objectives aligned with development timelines and regulatory milestones Preparing briefing packages, Q&A strategies, and scientific rationales Submitting formal meeting requests via agency-specific portals (e.g., CDER NextGen, EMA CESP, PMDA Gateway) Agency Engagement Execution Managing pre-meeting preparations, live discussions, and post-meeting follow-ups Capturing regulatory feedback and integrating it into development or submission strategies Country-Specific Dossier Adaptation Formatting dossiers to meet national agency requirements (e.g., SmPC for EMA, PMDA formats, eCTD SPL for USFDA) Localizing labeling, safety, and clinical documentation per regional standards Local Regulatory Liaison Real-time communication with country-specific health authorities Managing submission logistics and addressing queries via local representatives Translation & Multilingual Support Certified, regulatory-compliant translations of technical, clinical, and labeling documents Ensuring language conformity for packaging, patient information, and labeling materials Regulatory Intelligence & Procedural Insight Continuous monitoring of regional regulations, submission routes, and agency expectations Providing guidance on national procedures, risk mitigation strategies, and documentation timelines Commitment & Query Tracking Logging and tracking regulatory correspondence, query timelines, and commitments Maintaining audit-ready archives of all regulatory communications and interactions How Techsol Enables Global HA Interactions & Local Execution We understand that successful product registration depends on both global strategy and regional execution. Techsol offers a connected model of centralized regulatory planning combined with local market implementation to help sponsors achieve faster and smoother approvals. Our Comprehensive Approach: Techsol Life Sciences, our regulatory consulting team adopts a proactive, globally harmonized, and regionally adaptive approach to ensure effective interactions with health authorities and seamless local regulatory execution. Our methodology is structured around the following core aspects: Centralized Strategic Planning: Techsol defines a unified global regulatory interaction strategy that aligns with your product’s clinical, CMC, and safety milestones. We map the optimal pathways for IND, NDA, BLA, CTA, and MAA submissions, enabling synchronized planning and consistent messaging across jurisdictions. End-to-End Meeting Lifecycle Support: We manage the full lifecycle of agency meetings—from scheduling and briefing package preparation to Q&A development, rehearsals, and post-meeting correspondence. Our process-driven support ensures your teams are scientifically prepared and regulator-ready at every stage. Cross-Functional Coordination: Our consultants work closely with internal clinical, nonclinical, CMC, safety, and regulatory functions to ensure strategic alignment and cohesive communication. This collaboration results in a unified product narrative that resonates with regulatory agencies globally. Region-Specific Dossier Adaptation: Techsol adapts regulatory submissions to meet country-specific content, format, and procedural requirements. Whether for EU, UK, Japan, Canada, LATAM, MENA, or APAC markets, our experts ensure compliance with local agency expectations and technical standards. In-Country Regulatory Liaison: Leveraging our network of local affiliates and trusted partners, Techsol facilitates real-time interaction with health authorities. We oversee submission logistics, respond to regional queries, and ensure smooth navigation through in-country regulatory processes. HA Query & Commitment Tracking: We maintain a centralized system for tracking formal and informal agency communications. Techsol ensures timely drafting, review, and submission of responses, follow-ups, and regulatory commitments to maintain transparency and compliance during review cycles. Language & Translation Management: Techsol provides multilingual support for submission documents, including certified translations of clinical, technical, labeling, and artwork content. We ensure accurate localization and formatting in compliance with regional health authority requirements. Value proposition End-to-End Agency Meeting Support: From content development and Q&A strategy to post-meeting follow-up, Techsol manages the full lifecycle of regulatory engagements. USFDA-Focused Strength: Extensive experience supporting USFDA interactions, including Pre-IND, Pre-NDA/BLA, and written communications. In-Country Regulatory Specialists: Access to regional experts in Europe, Canada, Japan, LATAM, and APAC for local requirements, translations, and agency coordination. Multiregional Expertise: Support for EMA, MHRA, PMDA, TGA, Health Canada, and other authorities—ensuring compliance and alignment with evolving expectations. Integrated Global Execution: Bridging central regulatory strategies with localized

Regulatory Affairs Services Labeling & Artwork Compliance At Techsol, we deliver integrated labeling solutions that combine compliant content development, controlled versioning, and regulatory artwork review—ensuring globally aligned, audit-ready labeling throughout the product lifecycle. Request a Consultation Overview In today’s highly regulated life sciences environment, product labeling serves as both a compliance requirement and a critical tool for patient safety and communication. Inaccurate or outdated labels can delay market entry, trigger compliance issues, and compromise patient safety. At Techsol, we offer comprehensive labeling and artwork compliance services to ensure your product labeling is accurate, up to date, and fully aligned with regional and global regulatory expectations—from development through post-marketing. Our regulatory team has extensive experience in supporting both region-specific and global labeling requirements, including USFDA formats such as Structured Product Labeling (SPL), US Prescribing Information (USPI), and Patient Information Leaflets (PIL), as well as EMA-compliant formats like the Summary of Product Characteristics (SmPC). We also specialize in the development and maintenance of Company Core Data Sheets (CCDS) based on CIOMS guidelines. Techsol helps clients manage global labeling portfolios by ensuring cross-regional consistency, robust version control, and accurate localization of content in alignment with evolving health authority expectations. Labelling and Artwork Compliance Labeling and Artwork Compliance refers to the process of developing, reviewing, approving, and maintaining product labeling and packaging components in accordance with regulatory authority guidelines across different global markets. This ensures that all product-related information provided to healthcare professionals and patients is accurate, clear, consistent, and compliant. At Techsol, Labeling and Artwork Compliance is a regulated, lifecycle-driven process that combines scientific accuracy, regional formatting, content version control, and regulatory alignment across both core labeling (like CCDS) and regional adaptations (like USPI, SmPC, PIL, SPL, etc.) It plays a critical role in: Ensuring patient safety Meeting health authority expectations Avoiding market access delays Supporting successful product launches and lifecycle maintenance Labeling and Artwork Compliance Services: The scope of Techsol’s labeling and artwork compliance services spans core label development, regional adaptation, lifecycle management, and audit readiness throughout the product lifecycle: Company Core Data Sheet (CCDS) Development, maintenance, and version control aligned with global updates USFDA-Compliant Labeling Preparation and submission of USPI, Structured Product Labeling (SPL), and PIL & Medication Guides EMA and EU Labeling Compliance with SmPC, QRD templates, and Blue Box requirements Other Health Authority-Compliant Formats Canada (Product Monograph – PM), Japan (Interview Form – IF), Australia (Consumer Medicine Information – CMI), and others Labeling Lifecycle Management Handling of safety-driven updates, labeling variations, and risk mitigation strategies Regulatory Artwork Review Review and approval of cartons, blister packs, inner/outer packaging, and inserts/leaflets Global Harmonization & Localization Country-specific content adaptation, translation, and version tracking Change Control Integration Ensuring labeling updates are linked with internal and external regulatory changes Audit and Inspection Support Comprehensive labeling documentation traceability and CAPA response readiness Key Elements of Labeling and Artwork Compliance Techsol structures its labeling and artwork compliance process around the following critical components to ensure global regulatory alignment, quality, and efficiency: Core Labeling Creation • Development and maintenance of Company Core Data Sheets (CCDS) • Alignment with scientific, clinical, and safety data to define master product information Regional Labeling Adaptation • Authoring of USPI, SmPC, PIL, SPL, and other health authority-specific formats • Country-specific labeling and artwork updates based on regional regulatory requirements Version Control & Change Management • Integration with regulatory change control systems for traceability • Maintenance of an audit trail for all labeling revisions and approvals Mock-up and Artwork Review • Regulatory assessment of cartons, labels, inserts, and blister packs • Cross-functional review for content accuracy, layout compliance, and readability Translation & Localization • Development of health authority-compliant multilingual labeling content • Localization aligned with the CCDS and approved product labeling Labeling Lifecycle Management • Regular updates driven by safety signals, clinical data, or regulatory changes • Structured workflows to prevent discrepancies and ensure version synchronization Health Authority Query & Inspection Readiness • Preparation of responses to regulatory authority queries related to labeling • Support for audits, variations, and inspection documentation Digital Labeling & Submission Readiness • SPL (Structured Product Labeling) XML creation, validation, and publishing • Alignment with electronic submission standards (FDA ESG, EMA CESP, Health Canada) Regulatory Labeling and non-compliance consequences Issue Impact Regulatory Warning Letters / 483s FDA or EMA may issue formal observations for inaccurate, misleading, or missing labeling content. Product Recalls If labeling defects impact safety or effectiveness, regulators may mandate Class I, II, or III recalls. Import Alerts / Refusals Products may be barred from entering the US or EU markets due to mislabeling or non-compliance with local language or content requirements. Delayed Approvals Incorrect or incomplete labeling (e.g., SmPC, PIL, IFU) can delay marketing authorizations or post-approval changes. Labeling Supplements Rejection Failure to comply with guidance during CBE or PAS submissions may lead to refuse-to-file (RTF) actions. Civil or Criminal Penalties In cases of intentional misbranding, companies may face fines or legal action under FDCA 502/505 or EMA falsification laws. Our Expertise Includes: Core Labeling Development: CCDS, USPI, SmPC, PIL, and prescribing info across global markets. Structured Product Labeling (SPL): Preparation, validation, and submission to FDA systems. Labeling Lifecycle Management: Ongoing updates for new safety, clinical, or manufacturing data. Mock-up and Artwork Review: Compliance checks for carton, leaflet, blister, and label components. Change Control & QC: SOP-driven quality control and change implementation traceability. Localization Support: Version-controlled, region-specific labeling development in multiple languages. Audit Support: Labeling documentation prepared to withstand global audits and regulatory inspections. Our Value Proposition USFDA-Compliant Labeling – Expertise in SPL creation, USPI authoring, and FDA submission compliance. EMA & EU Labeling Expertise – SmPC, PIL, and multilingual content aligned with EMA regional requirements. Global CCDS Management – Development and updates of CCDS following CIOMS guidelines and company-level governance. Labeling Harmonization & Localization – Controlled content versioning, regional alignment, and localization workflows. Global Labeling Portfolio Oversight – Centralized management for multi-country updates, ensuring compliance and audit preparedness. Multilingual Artwork & Packaging Compliance – Regulatory review of artwork and packaging across markets, ensuring visual

Compier AE Intake & Integrated Mailbox Pharma companies are required to download files from the EV Web portal and Canada Vigilance based on active substances (not based on the company’s products). Due to this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs.  It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting. Common Regulatory Intake Challenges  Manual filtering of company specific AE cases from Eudravigilance Web and Canada Vigilance database and completing ICSR intake Lengthy redundant and error-prone process to compile Individual Case Safety Reports (ICSRs) and finish case processing Users have to download multiple excel files from the Canada Vigilance database and apply filters to segregate their company data Poor visibility on case volume processed from these regulatory safety databases with disconnected communication and no historical tracking Lack of awareness on reporting delays and other issues that could result as findings during audits and inspections Introducing Compier Intake & Mailbox Compier Intake enables seamless AE intake, receipt, and triaging from various sources such as PDFs, emails, etc. through automated data point check and import of safety cases directly into the safety database. It also has a built-in Inbox for distribution of safety case related emails to different business partners and vendors. It also enables automated case filtering and ICSR intake from safety data obtained from the Canada Vigilance and Eudravigilance database. Our platform automatically reads the product information from the E2B R3 files (from EV Web) and CSV files (from Canada Vigilance) and auto-creates a valid safety case without any manual intervention. Solution Features & Benefits >   Regulatory Intake provides various, ready to use dashboards and reports to manage the process efficiently. >   Dashboard for total cases processed in a specific time interval with details of success and non-success numbers >   Total number of cases received for a country and processed based on report type >   Multiple trend reports indicating total number of cases reported by time interval, source, product etc >   Reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Intake & Mailbox modules along with the required system integrations. Is the Compier Intake & integrated Mailbox solution validated? Compier Intake & Mailbox modules are part of the PVOps Management platform. All modules are GxP compliant and meet FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier Intake application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Aggregate solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Specialized & Niche Services Gene Therapy & Novel Treatments We provide comprehensive regulatory support for gene therapy products, guiding sponsors through every stage of development — from preclinical studies to marketing authorization and post-approval compliance. Request a Consultation Overview Gene therapies represent a rapidly evolving area of healthcare with unique scientific, technical, and regulatory complexities. Successful development and approval of these advanced therapies require specialized expertise to navigate stringent global regulatory frameworks. At Techsol, we provide comprehensive regulatory support for gene therapy products, guiding sponsors through every stage of development — from preclinical studies to marketing authorization and post-approval compliance. Our Expertise Strategic Regulatory Planning Key Services: Early Regulatory Intelligence Evaluation of current FDA and EMA guidelines for gene therapy (e.g., CBER Guidance, EMA ATMP regulations). Gap analysis for preclinical and clinical development readiness. Product Classification & Regulatory Pathway Assessment US: IND → BLA (CBER/OTAT, now Office of Therapeutic Products – OTP). EU: ATMP classification, CAT (Committee for Advanced Therapies) evaluation, MAA. Regulatory Roadmap Development Defining timelines, submission strategy, and interaction plan with FDA & EMA. Orphan designation, RMAT (US) / PRIME (EU) pathway evaluation. Pre-IND / Scientific Advice & Regulatory Interactions US FDA: Pre-IND meetings with CBER/OTP. RMAT designation request and guidance alignment. EU: ATMP classification request to EMA. Scientific Advice / PRIME eligibility request. Early dialogue with CAT & CHMP for development alignment. Techsol Support Includes: Meeting request preparation, briefing package authoring, and Q&A strategy. Representation during meetings and managing regulatory follow-ups. Nonclinical (Pre-Clinical) Regulatory Support Activities: Study Planning & Report Authoring: GLP-compliant safety, biodistribution, shedding, and tumorigenicity studies. Immunogenicity and germline transmission studies for viral vector-based therapies. Document Preparation: US: Nonclinical sections of IND & BLA Module 4 (CTD). EU: Nonclinical Summaries, Overviews, and Environmental Risk Assessments for MAA. Techsol Expertise: Template-based writing, QC, SME review, and alignment with latest FDA/EMA expectations. Clinical Development Regulatory Support Key Deliverables US FDA: IND preparation, amendments, and annual reports. EU: CTA submission, protocol assistance, IMPD preparation, and DSURs. Ongoing Compliance Safety reporting (SAE/SUSAR), patient follow-up requirements, and long-term follow-up plans for gene therapy trials. Techsol Approach Submission-ready CTD authoring, regulatory QC, and RIM (Regulatory Information Management) support. CMC / Manufacturing Regulatory Services Gene Therapy-Specific CMC Support: Vector characterization, potency assays, and comparability studies. Process validation and viral clearance studies. Submission Documentation: IND/BLA Module 3 (CMC) preparation for US. IMPD / MAA Quality Module for EU. Regulatory Interactions: FDA Type C meetings or EMA Quality & ATMP CMC consultation for complex issues. Marketing Authorization & Post-Approval Lifecycle Management US: BLA Submission & Review Management eCTD compilation, RTF readiness, and FDA query management. Labeling negotiations with CBER. Post-Approval Compliance: Annual reports, post-marketing commitments (PMCs/PMRs), long-term follow-up (LTR), REMS (if applicable). EU: MAA Submission & CHMP/CAT Interactions Dossier preparation, eCTD submission, RFI/LoQ management. Post-Approval PSUR/PBRER, risk management plan (RMP) updates, post-authorization safety studies (PASS), variations & renewals. Additional Specialized Services for Gene Therapy Orphan Drug Designation and Maintenance. RMAT / Breakthrough / PRIME expedited pathways. Environmental Risk Assessment (ERA) for EU. Long-term follow-up (LTR) study planning for integrating safety over 15 years. Advisory on new guidance updates (e.g., FDA Human Gene Therapy CMC, Clinical & Long-term Follow-up Guidance). Capabilities & Value Proposition Dedicated Gene Therapy Experts with in-depth knowledge of ATMP guidelines Global Regulatory Experience across US, EU, Japan, and emerging markets. Proven Track Record in handling complex CMC and clinical challenges. Cross Functional Collaboration with nonclinical, clinical, and manufacturing teams. Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Request a Demo Submit

Regulatory Affairs Services Regulatory Submissions Regulatory Submissions strategy: IND, CTA, NDA, ANDA, BLA, MAA, DMF, ASMF & other Dossiers management Labeling and Artwork Compliance Request a Consultation Overview In the dynamic regulatory landscape, getting submission strategy right is critical to minimizing delays, avoiding costly agency rejections, and accelerating product access to global markets. Whether you’re a biotech start-up submitting your first IND or a global pharma preparing for an MAA, Techsol delivers submission strategies with precision, speed, and regulatory confidence. At Techsol, we support end-to-end dossier development, review, and lifecycle management for all major regulatory markets including the U.S., EU, Canada, LATAM, and APAC. With expertise spanning IND, CTA, NDA, ANDA, BLA, MAA, DMF, ASMF, and more, we provide scalable solutions tailored to your product type—be it a gene therapy, biologic, or small molecule. Regulatory Submissions Strategy Regulatory Submissions Strategy is a proactive, cross-functional plan that defines how regulatory documents are prepared, reviewed, compiled, and submitted to health authorities for product approvals and lifecycle management. At Techsol, Regulatory Submissions Strategy goes beyond document delivery—it ensures that each submission is timely, complete, compliant with regional regulations like USFDA, EMA, PMDA), and aligned with the broader development and commercialization goals of the sponsor. Goals of Strategy: Accelerate review timelines Ensure consistent global dossier alignment Reduce submission rework and deficiencies Facilitate successful interactions with health authorities Scope of Regulatory Submissions Strategy A comprehensive regulatory submissions strategy spans early development through post-approval phases, encompassing the following key areas: Initial Applications IND (Investigational New Drug), CTA (Clinical Trial Application) NDA (New Drug Application), ANDA (Abbreviated NDA), BLA (Biologics License Application), MAA (Marketing Authorization Application) Regional equivalents across global health authorities Lifecycle Submissions Amendments: Modifications submitted during the review of an initial application (e.g., protocol changes, manufacturing updates) Variations (EU and other regions): Type IA, IB, and II variations based on risk and impact Supplements (US FDA): Prior Approval Supplements (PAS) – For major changes requiring FDA approval before implementation (e.g., changes in manufacturing site, formulation, or container closure system) Changes Being Effected (CBE-0, CBE-30) – For moderate changes that can be implemented with or shortly after notification to the FDA Renewals and Annual Reports to maintain marketing authorization and track post-approval commitments Post-Approval Changes aligned with regional regulatory expectations and categorized based on risk/impact. Techsol’s Regulatory Submission Excellence At Techsol, our regulatory submission strategy is built on precision, proactive planning, and global compliance expertise. We understand that every product’s development pathway is unique and so are the regulatory expectations across different health authorities. With over 15 years of experience with both investigational and marketing applications, we help clients avoid submission pitfalls by delivering: Complete Regulatory Strategy Development From early-stage gap analysis to post-approval maintenance, our end-to-end services ensure submission readiness across clinical, nonclinical, and CMC domains. Modular Authoring Excellence With dedicated experts for Modules 1–5, we produce technically sound, regulator-friendly dossiers tailored to regional requirements and product-specific nuances. Dossier Localization & Market Adaptation We tailor CTD content and structure to meet region-specific regulatory expectations maximizing global submission success. Real-World Submission Experience Our team has successfully led INDs, NDAs, BLAs, ANDAs, CTAs, MAAs, and DMFs across the US, EU, Canada, LATAM, and Asia-Pacific, including fast-track and orphan programs. Efficient eCTD Publishing & Lifecycle Tracking Using validated publishing tools and automated workflows, we maintain version control, ensure timely sequence delivery, and support global regulatory lifecycle management. Seamless Cross-Functional Coordination We work closely with CMC, clinical, and safety teams to ensure integrated submissions that align with development timelines and commercial goals. Whether it’s your first submission or your 50th, Techsol’s regulatory team provides the clarity, compliance, and confidence needed for successful global filings. Our Value Proposition USFDA-Focused Expertise: Proven success in high-priority submissions (INDs, NDAs, ANDAs, BLAs), including support for accelerated approval programs such as Fast Track, Breakthrough, and RMAT (Regenerative Medicine Advanced Therapy). Global Submission Experience: Comprehensive dossier management for EU, Health Canada, LATAM, APAC, and emerging markets, with localization and RMS/HMA coordination for EU centralized and decentralized procedures. High-Quality Authoring & Review: Specialized scientific and regulatory writing teams ensure completeness, clarity, and technical accuracy. Streamlined Submission Process: Integrated planning, gap assessment, and publishing tools reduce time to submission and agency response timelines. Flexible Support Models: Whether you need full-service submission support or targeted assistance for specific modules, Techsol scales to your requirements. Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Request a Demo Submit

Regulatory Affairs Services Process Standardization We address these challenges through end-to-end process standardization services tailored to U.S. FDA, EMA, Health Canada, PMDA, and ICH expectations. Whether you’re preparing for your first IND or managing a portfolio of global submissions, we help streamline operations from SOP creation to automation-enabled dossier workflows. Request a Consultation Overview In today’s fast-paced regulatory environment, life sciences companies must not only achieve compliance but sustain it across multiple products, regions, and functional teams. The lack of standardized processes often leads to inconsistent documentation, longer review cycles, and increased regulatory risk. At Techsol, we address these challenges through end-to-end process standardization services tailored to U.S. FDA, EMA, Health Canada, PMDA, and ICH expectations. Whether you’re preparing for your first IND or managing a portfolio of global submissions, we help streamline operations from SOP creation to automation-enabled dossier workflows. Process Standardization Consulting services: Techsol has deep domain experience in regulatory process standardization across the key functional areas to drive consistency, compliance, and cross-functional synergy. We provide consulting services to Sponsors and research organizations on the following services on the Process Standardization. Regulatory Operations Standardized eCTD publishing workflows Dossier compilation procedures Health authority response management protocols Clinical & Pharmacovigilance SOPs for site activation, monitoring, and close-out Serious Adverse Event (SAE) reporting workflows Clinical and safety data reconciliation processes Quality & Compliance QMS documentation templates and versioning Deviation and CAPA management procedures Audit trail capture and oversight mechanisms CMC & Manufacturing Harmonized batch record documentation Control strategy implementation workflows Change control and notification procedures Labeling Operations Label version control and tracking Regulatory compliance checks CCDS (Company Core Data Sheet) harmonization Clinical & Non-Clinical Process Alignment Techsol has established a standard, and fully validated clinical and non-clinical templates which are acceptable by Regulatory authorities. Clinical Reports Clinical Overviews Clinical Summaries Integrated Clinical Reports Non Clinical Reports Non-Clinical Summaries Non- Clinical Overviews Our Expertise: At Techsol, our deep industry experience and hands-on execution have enabled life sciences clients to standardize and streamline regulatory processes with precision. Our proven capabilities include: SOP Development & Optimization We have successfully designed and implemented modular, audit-ready Standard Operating Procedures (SOPs) across diverse regulatory functions—including submissions, labeling, change control, and HA correspondence. These SOPs are tailored to product complexity and regional compliance expectations (ICH, USFDA, EMA, etc.). Regulatory Templates & Checklists Our team has developed validated, submission-ready templates and QA checklists for INDs, NDAs, BLAs, MAAs, DMFs, and labeling documents. These tools have accelerated submission preparation cycles while ensuring consistency, traceability, and completeness across teams. Submission Workflow Automation We’ve integrated automation-ready workflows for eCTD publishing, version control, and submission tracking in real-world projects. This has enabled regulatory teams to reduce manual interventions, maintain control over content versions, and meet tight submission deadlines. Labeling Lifecycle Frameworks From USPI and CCDS to SmPC, SPL, and mock-ups, Techsol has built end-to-end labeling frameworks that support global harmonization. We’ve helped clients synchronize regional updates and minimize non-compliance risks during safety-driven labeling changes. Change Management SOPs Techsol has supported multiple post-approval variation workflows by deploying structured SOPs, risk assessment matrices, and change control tools—enabling clients to manage global product changes effectively while maintaining continuous compliance. Global Compliance Alignment Through cross-functional collaboration and standardization, we’ve helped clients establish harmonized regulatory practices across the U.S., EU, Canada, and APAC. Our frameworks are scalable across product types and therapeutic areas, supporting efficient multi-region submissions and lifecycle updates. Our Value Proposition 15+ Years of Global Regulatory Expertise Trusted partner supporting U.S., EU, APAC, LATAM, and MENA regulatory operations. Led by Techsol SMEs with former roles at US FDA, EMA, and key international regulatory bodies. Comprehensive Multi-Agency Compliance Fully aligned with ICH, US FDA, EMA, Health Canada, PMDA, MHRA, TGA, LATAM, and MENA regulatory frameworks. Ensures audit-ready submissions and robust global regulatory strategy. End-to-End Product Lifecycle Management Expertise spanning IND/IMPD, NDA/BLA/MAA submissions, and post-approval variations. Supports faster time-to-market with smooth interactions across multiple health authorities. Scalable & Flexible Solutions for Sponsors Tailored frameworks for emerging biotech, mid-size pharma, and large global enterprises. Adapts to varying regulatory complexities and submission volumes. Validated, eCTD-Enabled & SOP-Driven Processes Leverages proven SOPs, templates, and checklists from successful real-world submissions. Reduces manual effort, minimizes rework, and accelerates submission readiness. Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Request a Demo Submit

Specialized & Niche Services Modernization of Cosmetics Regulation Act (MoCRA) Compliance Solutions Request a Consultation Overview The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a transformative shift in how cosmetics are regulated in the United States. As the first major update to FDA cosmetic laws since 1938, MoCRA enhances FDA’s authority to ensure the safety and transparency of cosmetic products, impacting manufacturers, contract manufacturers, and brand owners alike. At Techsol Life Sciences, we support cosmetic manufacturers, importers, and distributors in aligning with MoCRA’s evolving requirements through our Regulatory Compliance and Advisory Services. We provide end-to-end solutions that ensure your products are not only market-ready but inspection-ready. Services Offered at Techsol Facility Registration & Renewal Assistance with initial FDA registration of domestic and foreign facilities involved in manufacturing or processing cosmetic products. Timely biennial renewal support to maintain valid facility registrations. Guidance on maintaining registration eligibility and avoiding suspension due to product safety concerns. Cosmetic Product Listing Preparation and submission of FDA-compliant product listings including formulation details, product categories, and responsible person data. Annual update management to ensure continued compliance. Safety Substantiation Consulting Evaluation of existing safety data and preparation of safety substantiation documentation. Support in identifying scientifically valid alternatives to animal testing. Record-keeping guidance for maintaining safety data in an FDA-accessible format. Serious Adverse Event Reporting (SAER) Setup and implementation of internal monitoring systems for identifying and tracking adverse events. Preparation and electronic submission of Form FDA 3500A for serious adverse events within the 15-business-day reporting window. Ongoing support for follow-up reporting and inspection readiness. Good Manufacturing Practices (GMP) Advisory Strategic guidance to establish and implement cosmetic GMPs in line with upcoming FDA regulations. Conducting internal GMP gap assessments, SOP development, and quality system design. Support in documenting manufacturing controls for FDA inspection compliance. Fragrance Allergen & Talc-Testing Compliance Consulting support for fragrance allergen labeling as per anticipated FDA requirements. Development of testing protocols and vendor qualification for asbestos testing in talc-containing cosmetics. MoCRA Readiness Audits & Regulatory Strategy Conducting internal MoCRA readiness assessments for product portfolios and facilities. Creation of a compliance roadmap, including required documentation, reporting systems, and stakeholder roles. Ongoing regulatory intelligence tracking for updates on PFAS assessments, GMP rulemaking, and additional FDA guidance. Value Propositions Customized Compliance Roadmaps Digital Tools to Streamline FDA Submissions Scalable Services for Startups to Global Brands Cross-functional Support Teams (RA, QA, IT) Proven Regulatory Expertise Request a Demo Submit

Regulatory Overview Highlights of Our Regulatory Team Accomplishments Request a Consultation Key Achievements and Global Regulatory Impact Techsol’s regulatory team has a proven track record of resolving complex clinical hold issues, enabling the initiation of critical Phase 1 and Phase 3 trials across therapeutic areas including Cardiovascular, Antiviral, Vaccines, Ophthalmology, Oncology, Neurology: anti-migraine, anti-epileptic, Alzheimer’s, Parkinson’s, and antidepressants schizophrenia. Also, we have successfully submitted multiple INDs and Phase 2 protocols for start-ups and mid-sized companies, including novel delivery technologies like combination products, Cell Therapy, Gene Therapy, and Rare Diseases. Key Achievements and Global Regulatory Impact Resolved clinical hold issues to enable: Phase 3 trial initiation for schizophrenia. Phase 1 studies for a start-up and a leading ocular company. Successfully submitted: IND and Phase 2 protocol for a start-up. IND for a mid-sized company using microneedle array technology. Led regulatory meetings including: 8 Pre-IND, 3 End-of-Phase 2 (EOP2), and multiple INTERACT meetings with FDA. 4 Scientific Advice meetings with EMA. 50+ PIND meetings (FDA), 16 with EMA, and multiple meetings with COFEPRIS, ISP, ANVISA, DIGEMID, PMDA, KFDA, GCC (Saudi Arabia & MoH), and NMPA. Assisted clients with: NDA re-submissions following Complete Response Letters (CRLs). IND preparation and submissions (22 INDs filed overall, including 5 in neuroscience and 3 in oncology). Obtained critical regulatory designations: Approval for a New Chemical Entity (NCE) with DCGI, India RMAT for two regenerative medicine products. Fast Track and QIDP status for seven antibiotic drugs under the GAIN Act. 12 Orphan Drug Designations across neurological, ocular, and rare diseases (FDA and EMA). Developed and executed a 505(b)(2) regulatory strategy for an IV formulation of an MS drug: Held PIND meeting with FDA, drafted BE protocol, obtained orphan designation, and supported IND/NDA filings. Successfully negotiated regulatory approvals: 1 BLA, 2 NDAs, 3 ANDAs with FDA. 2 biosimilar marketing authorizations with COFEPRIS, DIGEMID, ISP, and ANVISA. Engaged with global agencies to secure recognition of “unmet medical need” for an antibiotic (FDA, EMA, NMPA, SAHPRA, ANVISA). Provided regulatory strategy for stem cell and regenerative therapies targeting: Brain trauma, wound healing, and arthritis (led INTERACT meetings with FDA). Built and implemented quality infrastructure: Established Quality Assurance (QA) systems, Quality Control (QC) procedures, and SOPs for product development and release for multiple clients. Audited CMO facilities and clinical sites (including for the COVAXIN pivotal trial in India) to ensure regulatory compliance. Developed EU-compliant Pharmacovigilance systems and QPPV activities. Request a Demo Submit

Regulatory Capabilities Overview Fullscale Regulatory Solutions & Capabilities With deep regulatory expertise and proven capabilities across global markets, we help companies navigate complex requirements with precision, efficiency, and compliance at every stage of the product lifecycle Request a Consultation Fullscale Regulatory Expertise and Solutions Coverage – Clinical Development to Post Approval Support At Techsol Life Sciences, Our regulatory strategy is driven by a highly experienced team with deep-rooted expertise in global regulatory science and clinical development. Our leadership includes former U.S. FDA Regulatory Subject Matter Experts (SMEs) and senior regulatory professionals with nearly three decades of experience in regulatory affairs, drug development strategy, and Chemistry, Manufacturing, and Controls (CMC). Our regulatory leadership has held key positions within the U.S. FDA, EU and the biopharmaceutical industry, contributing to the successful development and approval of products across multiple therapeutic areas. Their in-depth understanding of regulatory frameworks and evolving global requirements underscores Techsol’s commitment to compliance, regulatory excellence, and accelerated patient access to safe and effective therapies worldwide. Key Achievements and Global Regulatory Impact As part of Techsol’s regulatory leadership, Our Regulatory SMEs have, Led and contributed to over 100+ global regulatory approvals, including: Marketing Authorizations 9 (BLAs and NDAs) Biosimilar Approvals in 2 emerging markets Abbreviated New Drug Applications 23 (ANDAs)Orphan Drug Designations 12 (ODDs)7 Qualified Infectious Disease Product (QIDP) Designations55+ Investigational New Drug (IND) submissions Strategic Regulatory Engagements Conducted over 100+ regulatory agency meetings, bringing strategic clarity and negotiation skills across multiple global markets: Innovations in Regulatory Science Our strategic leadership has directly shaped regulatory frameworks: Highlights of Our Regulatory Team Accomplishments Techsol’s regulatory team has a proven track record of resolving complex clinical hold issues, enabling the initiation of critical Phase 1 and Phase 3 trials across therapeutic areas including Cardiovascular, Antiviral, Vaccines, Ophthalmology, Oncology, Neurology: anti-migraine, anti-epileptic, Alzheimer’s, Parkinson’s, and antidepressants schizophrenia. Also, we have successfully submitted multiple INDs and Phase 2 protocols for start-ups and mid-sized companies, including novel delivery technologies like combination products, Cell Therapy, Gene Therapy, and Rare Diseases. Expertise – Submissions, Agencies, Geo’s, Product Types & Tools Introducing TOTALRegulatory – PV Function of the Future TOTALRegulatory is a modern delivery framework enables sponsors to move beyond compliance toward proactive, efficient, and insight-driven safety monitoring ensuring patient safety remains at the heart of life sciences innovation. Learn more about TOTALRegulatory Content Authoring Services Regulatory Briefing Documents Read More CMC Content Authoring Read More Non-Clinical Content Authoring Read More Clinical Content Authoring Read More Regulatory Affairs Services Regulatory Strategy Read More Regulatory Intelligence Read More Process Standardization Read More Regulatory Submissions Read More Gene Therapy Products Read More Labeling and Artwork Read More HA Interactions & Country Support Read More Regulatory QMS & Audit Support Read More Pre-Submission Meetings: IND Read More Pre-Submission Meetings: NDA Read More Pre-Submission Meetings: BLA Read More Regulatory Operations Services eCTD Publishing and Submission Read More eCTD Lifecycle & Updates Read More eCTD Compilation & Validation Read More eCTD Submissions to HA Read More Gap Analysis for CTA & MAA Read More Post-Approval Gap Analysis Read More Artwork & Labeling Read More SPL Conversions & RLD Updates Read More QRD Preparation-EMA Read More Local Labeling & Translations Read More SmPC & ePI Read More Labeling Compliance & Advisory Read More REMS & RMP Plans Read More Life Cycle Management Services Regulatory Life Cycle Management Read More CMC Management Read More Global Market Expansion Read More Electronic Documents & Data Read More Biosimilars & Biologics Read More Request a Demo Submit

Connecting the Pharmacovigilance Ecosystem with Confidence and Compliance In the highly regulated world of pharmacovigilance, seamless integration between your safety database and other enterprise applications is critical to ensuring compliance, improving efficiency, and enabling proactive safety oversight. Our specialized integration services for Oracle Argus Safety help life sciences organizations build a robust, connected PV ecosystem tailored to their operational and regulatory needs. Our Integration Expertise with Argus Safety Clinical System Integrations EDC Platforms (e.g., Medidata Rave, Veeva EDC, Oracle InForm) for AE/SAE case intake during clinical trials CTMS (e.g., Oracle Siebel CTMS, Veeva CTMS) for real-time access to study and site information Regulatory Systems RIM Systems (e.g., Veeva Vault RIM, Ennov, ArisGlobal) to streamline product registration and labeling updates eCTD Tools for electronic submissions Regulatory Authority Gateways Full support for E2B (R3) gateway submissions to: EMA (EV Gateway) FDA ESG PMDA Gateway Health Canada and other global authorities Signal & Risk Management Tools Integration with Empirica Signal, Qlik/Spotfire dashboards, and other tools for signal detection and risk analysis Medical Information & Complaint Systems SCIMAX MI, Salesforce, TrackWise, SAP QM integrations for MI and product quality complaints Literature & Intake Automation Connections with Embase, PubMed, and literature automation tools for case intake from global scientific sources AI/ML-enabled automation for email and document-based case capture ERP, MDM, and Quality Systems Integration with SAP, Oracle Fusion, and MDM platforms for consistent product and license data Links with QMS and DMS platforms (e.g., Veeva Vault, MasterControl) for documentation and compliance tracking Why Choose Us for Argus Integration? Validated Integration Frameworks aligned with GxP and compliance standards Pre-built Connectors for faster deployment and lower risk Global PV Expertise to guide configuration, testing, and go-live support Proven Track Record with integration projects across sponsors, CROs, and regulatory partners Let’s Power Your Connected Safety Landscape Whether you’re implementing Argus for the first time, upgrading, or looking to optimize system interoperability, our team ensures your integrations are secure, scalable, and compliant. Our Full Portfolio of Technology Services Oracle Argus Safety One Cloud Consulting Services Read More AccelSafety – Oracle Argus Safety & Signal Database Read More Oracle Empirica Signal & Topics Cloud Services Read More Axway E-Submission Gateway Consulting Services Read More Argus Safety Service Desk (ASD) Read More Safety Database & Systems Migration Services Read More Safety Analytics, Insights & Reporting Services Read More Request a Free Consultation Submit

Intake & Correspondence Manual case intake remains one of the most resource-intensive and error-prone steps in the pharmacovigilance lifecycle. As safety data grows in volume and complexity, relying on manual processes creates significant risks and inefficiencies  Comon Intake Challenges: Manual extraction of safety information from emails, scanned PDFs, call transcripts, and handwritten documents requires significant time and human effort Manual data transcription often leads to incomplete or incorrect entries, impacting case quality and downstream processing Delays in capturing and triaging critical adverse event information can result in missed regulatory timelines and compliance breaches Highly trained PV professionals spend significant time on repetitive, low-value tasks like reading documents and entering dataManual processes increase the risk of human error, missed data points, or improper case triage—all of which can lead to findings during audits or inspections Introducing Compier Intake – Inbox & Correspondence It is a simplified multi-channel adverse event case intake, receipt and triaging solution with advanced semi-automation capabilities to facilitate fast and intelligent case processing. Compier Intake enables seamless AE intake, receipt, and triaging from various sources such as PDFs, emails, etc. through automated data point check and import of safety cases directly into the safety database. It also has a built-in Inbox for distribution of safety case related emails to different business partners and vendors. It also enables automated case filtering and ICSR intake from safety data obtained from the Canada Vigilance and Eudravigilance database. Compier PV Ops Intake Automation and Agentic AI solutions are designed to transform this critical first step of the case lifecycle by leveraging intelligent automation, LLMs, and PV-trained agentic AI to reduce human workload, accelerate turnaround times, and enhance data quality. Our agents extract relevant data points like adverse event terms, product details, reporter information, seriousness, and timelines streamlining the intake process before cases even enter Argus Safety or other drug safety systems from various structured and unstructured sources such as Emails & attachments (PDF, Word, scanned documents), Medical Information systems, Product complaint portals, Literature databases (e.g., Embase, PubMed), Call center transcripts and voice-to-text sources. Key Benefits of Compier PV Ops Intake Automation & Agentic AI Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Intake & Mailbox modules along with the required system integrations. Is the Compier Intake & integrated Mailbox solution validated? Compier Intake & Mailbox modules are part of the PVOps Management platform. All modules are GxP compliant and meet FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier Intake application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Aggregate solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Compier PV Ops Modules Compier PV Ops & Agentic AI Read More Intake – Literature Screening Read More Intake – Regulatory Intake Read More ICSR Tracking & QA Read More Reports & Documents – Aggregate Reports Read More Reports & Documents – Agreements & Reconciliation Read More Reports & Documents – PSMF Management Read More Request a Demo Submit