Chemistry, Manufacturing & Controls (CMC) LCM

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.

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:

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:

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:

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

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

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

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:

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 Changes, and Manufacturing Process Optimizations

At Techsol, we support pharmaceutical and biopharma companies through complex Chemistry, Manufacturing, and Controls (CMC) changes, including manufacturing site transfers, equipment modifications, and process optimizations.

Changes to manufacturing sites, equipment, or processes require comprehensive regulatory strategy, meticulous documentation, and timely submissions to relevant Health Authorities (HAs). Each change is scientifically justified, appropriately classified according to regulatory guidelines, and submitted via the correct regulatory mechanism (e.g., variation, supplement, amendment) in alignment with regional regulations.

Our Services Include:

Manufacturing Site Transfers

Regulatory support for intra- and inter-company transfers of drug substance and drug product manufacturing.
Gap analyses and dossier updates reflecting site-specific process and control data.
Preparation of comparability protocols, validation/qualification plans, and bridging strategies to support regulatory filings.
Coordination of country-specific submission strategies, including FDA Prior Approval Supplement (PAS), EMA Type II variations, MHRA notifications, and others.

Equipment Changes

Regulatory impact assessments evaluating changes to equipment and potential effects on critical quality attributes (CQAs).
Updates to process validation, cleaning validation, and equipment qualification documentation for submission purposes.
Preparation and submission of regulatory supplements or variations, supported by scientific rationale.

Manufacturing Process Optimizations

Regulatory evaluation of process scale-up, synthetic route modifications, and process parameter adjustments.
Classification of changes per regulatory frameworks to define submission requirements and strategies.
Compilation of process development data and justification documentation to assure continued product quality and safety.

Our Expertise and Value Proposition

Integrated Technical & Regulatory Expertise: Our experienced regulatory experts combine deep manufacturing knowledge with regulatory insight to facilitate smooth execution of complex post-approval changes
Global HA Submission Experience: We have successfully managed and submitted regulatory dossiers to major Health Authorities such as FDA, EMA, MHRA, TGA, and others, utilizing in-depth expertise of region-specific regulatory requirements
Risk-Based, Strategic Approach: Our Regulatory team has utilized a scientifically driven, risk-based methodology to assess change impacts, successfully minimizing regulatory obstacles and expediting approval processes
Supply Continuity and Compliance: Techsol Regulatory team will prioritize Regulatory compliance and uninterrupted market supply during site transfers, equipment changes, and process optimizations

Post Approval Commitments:

Stability Protocol and Specification Updates

At Techsol, we provide expert regulatory support for stability protocol design, updates, and specification modifications, ensuring compliance with global regulatory expectations and consistent product quality throughout the lifecycle.

As stability studies and specifications are core components of Module 3 (Quality), any updates require strategic planning, scientific justification, and precise documentation to meet the requirements of Health Authorities such as the FDA, EMA, MHRA, and others.

Our Services Include:

Stability Protocol Development and Updates

Specification Revisions

Test parameters
Acceptance criteria
Analytical methods
Reference standards

Our Expertise and Value Proposition

ICH & Market-Specific Expertise: Our Regulatory team will ensure that all updates are aligned with ICH Q1/Q6A guidelines and local HA expectations
Regulatory Impact Assessments: Techsol Regulatory experts will provide accurate classification of updates (e.g., Type IB, Type II, CBE-30, PAS) and develop effective submission strategies
Scientific Justification: Our team crafts robust rationales supported by real-time and accelerated data to reduce the risk of HA rejections or questions
End-to-End Support: Our Medical and Regulatory experts have extensive experience in drafting stability protocols, updating dossiers, and managing submissions. We also provide comprehensive lifecycle support for stability and specification changes

Support for Drug Master File (DMF/ASMF) Updates

A Drug Master File (DMF) is a confidential, detailed document submitted to regulatory authorities (most commonly in the United States) by a manufacturer or supplier of an active pharmaceutical ingredient (API), excipient, or other components used in drug products. The DMF contains comprehensive information about the manufacturing process, quality controls, specifications, stability data, and facility details related to the ingredient or material. The DMF allows the holder (usually the API manufacturer) to provide detailed technical information to the regulatory authorities without disclosing proprietary or confidential details directly to the drug product manufacturer. It supports the drug product manufacturer’s regulatory submissions by referencing the DMF to demonstrate the quality and safety of the components used.

An Active Substance Master File (ASMF) serves a similar purpose but is the term used primarily in the European Union and other regions following EMA guidelines. It contains detailed information about the active substance used in a medicinal product. The ASMF facilitates the regulatory review process by allowing the active substance manufacturer to submit confidential information about the substance to regulators, while the finished product manufacturer submits a separate dossier referencing the ASMF. This separation protects intellectual property while ensuring compliance.

Key Features of DMF/ASMF

Confidentiality: Protects proprietary manufacturing and quality data from disclosure beyond regulatory agencies
Support for Regulatory Submissions: DMFs/ASMFs are referenced in marketing authorization applications (MAAs) or abbreviated new drug applications (ANDAs) to substantiate the quality of components
Comprehensive Technical Content: Includes detailed descriptions of manufacturing processes, quality controls, validation protocols, stability studies, and manufacturing site qualifications
Mandatory Updates: Regulatory compliance requires that DMFs/ASMFs be kept current through timely submission of amendments or supplements reflecting any changes in manufacturing or control strategies
Regulatory Review: Regulatory authorities review DMF/ASMF submissions during product evaluation but do not formally “approve” these files; rather, they assess their adequacy as part of the overall dossier review

Techsol offers comprehensive regulatory support for the preparation, updating, and maintenance of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs). Our expertise ensures that DMF/ASMF remain compliant with Health Authority requirements, facilitating smooth reviews and uninterrupted supply of active pharmaceutical ingredients (APIs) and related substances.

We assist clients in managing all aspects of DMF/ASMF updates, from data compilation to regulatory submissions, supporting ongoing product lifecycle activities and regulatory commitments.

Our Services Include:

Our Expertise and Value Proposition

Regulatory Expertise and Compliance Management: Our team has extensive knowledge in global regulatory standards, including FDA, EMA, and ICH guidelines, essential for successful DMF/ASMF submissions
Robust Document Management System (DMS): Techsol’s regulatory team utilizes a secure, centralized document management system designed to handle complex, version-controlled documentation
Change Control and Workflow Automation: Our regulatory team employs automated workflows and rigorous change control processes to ensure every modification in the DMF/ASMF is thoroughly reviewed, approved, and systematically documented
Data Integration and Validation: Techsol has the capability to integrate data from diverse sources such as analytical reports, stability data, and batch records
Audit Readiness and Reporting: We provide support in generating comprehensive reports and maintaining detailed audit trails, ensuring efficient preparation for inspections and regulatory audits related to DMF/ASMF submissions