Compare CDMOs with regulatory affairs capabilities for CMC documentation, filing support, and global regulatory strategy across FDA, EMA, and other agencies.
29 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.
Czech Republic
We provide our clients, both local and international pharmaceutical and chemical companies, with services performed in a professional and timely fashion, which enables them to accomplish their research goals in drug discovery and crop protection.
Spain
Astrum is a full-service CRO delivering Phase I–IV clinical development and REW, supported by our 64-bed hospital-based Phase I Unit in Porto and operational expertise across Europe and beyond.
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China
CelluPro, Ltd., headquartered in Yantai, China, specializes in the development and production of GMP-grade serum-free culture media for mammalian cells, and is committed to providing serum-free culture medium products and professional technical services at all stages from early development to commercial production process.