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)
SGS
Brazil
SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.
Small Molecule Drug ProductFormulation DevelopmentFill/Finish (Vials)
SIDEFARMA
Portugal
SIDEFARMA is a Portuguese CMO with over 45 years of experience, specialized in the manufacture of small and medium-size batches of solid dosage forms (coated tablets, tablets, capsules), semi-solids (creams, gels, ointments), and liquid pharmaceuticals. The company provides contract manufacturing, contract packaging, and contract development services following European quality standards, while also commercializing its own branded pharmaceutical products.
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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