Compare CDMOs with regulatory affairs capabilities for CMC documentation, filing support, and global regulatory strategy across FDA, EMA, and other agencies.
621 companies listed
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.
India
Caplin Point Laboratories is a fully integrated Indian pharmaceutical company with a dominant presence in Latin America and Francophone Africa, and a growing presence in the US and EU. Through its subsidiary Caplin Steriles, the company manufactures sterile injectables, ophthalmic products, pre-mix bags, and pre-filled syringes, with 46 FDA-approved products.
Taiwan
Cenra Pharma (formerly CCPC, China Chemical & Pharmaceutical Co.) is a Taiwanese pharmaceutical company established in 1952 that develops and manufactures APIs and generic drugs, also providing CMO/CDMO services. The company has FDA and PMDA facility approvals, PIC/S GMP compliance, and offers services from API selection through formulation development and commercial manufacturing. Cenra specializes in high-potency drugs including immunosuppressants and oncology drugs, with dedicated production lines for penicillins, cephalosporins, carbapenems, and immunosuppressants.
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.