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)
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Small Molecule Drug ProductOral Solid DoseFormulation Development
PeptiStar Inc.
Japan
PeptiStar is a Japan-based CDMO specializing in the development and cGMP manufacture of peptide and oligonucleotide APIs. From its 10,500 m² R&D and manufacturing site in Settsu, Osaka, the company supports programs from milligram-scale research material through clinical and commercial production. PeptiStar works with complex peptide structures, including long-chain, cyclic, branched and constrained peptides, non-natural amino acids and peptide conjugates. Its route-flexible manufacturing platform includes conventional and microwave-assisted SPPS, STag-PS and SYNCSOL liquid-phase technologies. Integrated downstream capabilities include preparative and continuous chromatography, membrane concentration and lyophilization, with 300 L filter reactors, chromatography columns up to 450 mm and lyophilizers up to 500 L. Purification and subsequent processing are conducted in Class 100,000 controlled areas. PeptiStar also develops and manufactures oligonucleotide APIs and peptide–oligonucleotide conjugates. The company was recognised by Exelixis as its 2025 CDMO of the Year.
Peptide APIOligonucleotide APIAPI 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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