Capability
Regulatory Support CDMOs
Compare CDMOs with regulatory affairs capabilities for CMC documentation, filing support, and global regulatory strategy across FDA, EMA, and other agencies.
621 companies listed
About Regulatory Support Services
Regulatory support from CDMOs covers the Chemistry, Manufacturing, and Controls (CMC) section of regulatory submissions. This includes drug substance and drug product specifications, analytical method descriptions, manufacturing process descriptions, stability data, and container closure system information. CDMOs with regulatory affairs teams can prepare complete CMC modules (Module 3 in CTD format) ready for IND, NDA, BLA, or MAA submissions.
Global regulatory strategy becomes important for products targeting multiple markets. CDMOs with experience across FDA, EMA, PMDA, and other regulatory agencies can advise on: harmonized specifications, common technical document preparation, agency-specific requirements, and inspection readiness. This expertise accelerates filing timelines and reduces the risk of regulatory deficiency letters.
Companies (621)
HAS Healthcare Advanced Synthesis SA
Switzerland
HAS Healthcare Advanced Synthesis SA, based in Biasca, Switzerland, is a full-service CDMO with over 40 years of experience in pharmaceutical development and manufacturing. The company recently acquired Cerbios-Pharma SA to create a leading international CDMO group, backed by 65 Equity Partners.
Small Molecule APIFormulation DevelopmentAnalytical Services
High Force Research Ltd
United Kingdom
High Force Research Ltd (HFR) is an independent UK-based CRO and CDMO established in 1988, located in Durham. The company provides specialist chemistry-led research, development, and cGMP manufacturing services for the pharmaceutical, materials science, and fine chemicals industries. HFR bridges expertise from early-stage R&D through to commercial manufacturing with a chemistry-first approach.
Frequently Asked Questions
What CMC documentation do CDMOs prepare?+
CDMOs typically prepare: Module 3.2.S (Drug Substance) -- manufacturing process, controls, specifications, stability. Module 3.2.P (Drug Product) -- formulation, manufacturing process, specifications, stability. Analytical method descriptions and validation reports. Batch records and certificates of analysis. Comparability protocols for manufacturing changes. Environmental assessments where required.
How does CDMO regulatory support differ from CRO regulatory support?+
CROs handle clinical and non-clinical regulatory submissions (Module 2 summaries, clinical study reports, safety data). CDMOs handle manufacturing-related CMC documentation (Module 3). Both contribute to the overall regulatory package. A CDMO with strong regulatory support can prepare the CMC sections independently, reducing the need for the sponsor to employ dedicated CMC regulatory staff.
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