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)
Danhson
Bulgaria
Danhson is a Bulgaria-based pharmaceutical holding company established in 2015, with group companies including Vetprom AD (65+ years of manufacturing history) and Danapha Pharmaceutical in Vietnam. The company develops, produces, and markets pharmaceutical products (Rx and OTC), food supplements, and cosmetics, with CMO/CDMO services. Danhson has invested BGN 50 million in a new production site with separate workshops for ampoule forms, liquid forms, semisolid, and biological products.
Small Molecule Drug ProductOral Solid DoseFormulation Development
Davipharm
Vietnam
Davipharm (Dat Vi Phu Pharmaceutical JSC) is a Vietnamese pharmaceutical manufacturer and member of the Adamed group, holding EU GMP certification. The company manufactures over 300 generic drug products at its facility in Binh Duong, Vietnam, and offers CMO/CDMO services including high-potency drug manufacturing. Davipharm recently expanded its capacity and capabilities in high-potency manufacturing.
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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