CMC Content Authoring - Techsol Life Sciences

Content Authoring Services

CMC Content Authoring

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 (CEPs) – Authoring and lifecycle management to maintain compliance with Ph. Eur. monographs, including updates for monograph revisions.

Post-Approval Compliance & Regulatory Intelligence

Techsol’s lifecycle management services extend to labeling updates, product maintenance, and audit-ready documentation to support global regulatory inspections and pre-approval audits. Our team continuously monitors global regulatory intelligence, including FDA CMC Post-Approval Changes (2023), EMA Variations (EC 1234/2008), and ICH Q12/Q13 updates, to ensure that every submission reflects current regulatory expectations and mitigates the risk of deficiency letters or delays.