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)
Made Scientific
United States
Made Scientific is a US-based cell therapy CDMO specializing in development and GMP manufacturing of cell-based therapies including T cells, NK cells, HSCs, MSCs, iPSCs, and TILs. The company provides services from pre-clinical support through Phase I-III clinical trials and commercial enablement, including process and analytical development, GMP cell banking, drug product manufacture, aseptic fill and finish, and QC lot release and stability testing. FDA-registered with FEI number and operations including API manufacture, analysis, labeling, manufacturing, and packaging.
Cell & Gene TherapyCell TherapyAnalytical Services
Magle Chemoswed AB
Sweden
Magle Chemoswed AB is a Swedish CDMO serving pharmaceutical and medical device companies with comprehensive services from development through manufacturing on a contract basis. The company operates a full cGMP and ISO 13485 production site in Malmo with five dedicated manufacturing suites. Services include analytical development, process development, solid state characterization, freeze drying (lyophilization), small-scale vial fill and finish, and inhalation drug product development. FDA inspected (3 inspections: 1 NAI, 2 VAI).
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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