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Services | Pharmax

Regulatory Support

Regulatory Support -  To achieve FDA/COS approval seems a complicated and difficult mission. We offer a QA and regulatory package including DMF/VMF/EDMF filing, source qualification, cGMP auditing, CAPA, and quality engineering management. We are proud to have obtained a number of successful FDA approvals of our contract API manufacturers since 2005. In Sep. 2009, we helped through our contract manufacturer of Lincomycin HCl, NCPC Huanluan, in successfully passing the FDA re-audit with Zero 483. In Oct. 2012, our on-site QA and regulatory support had helped CSPC Zhongrun to successfully pass the U.S. FDA inspection for Penicillin G Potassium.