Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.

Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have ...

Dublin, Sept. 18, 2025 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Oct 20th - Oct 21st, 2025)" training has been added to ...

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against ...

Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "Good Manufacturing Practices (GMP) 101" training has been added to ResearchAndMarkets.com's offering. This GMP Compliance training course is designed to ...