Dr. WANG Yuan, Chairman of 2Y-Chem, Ltd. visited Scitech Pharmaceuticals, and Dr. WANG gave a detailed explanation on the key elements in the development of new chemical drugs.
The two sides had an in-depth exchange on CMC information in drug registration application, potential problems leading to CMC suspension, common problems in CMC filing and key points of CMC in clinical trial application.
Dr. WANG suggested that a good CMC in IND should be like telling an easy-to-understand story, reflecting what your product is, how the product is developed, how the product is manufactured, how the product is tested, how stable it is, and how it is used in the clinic in a concise and easy-to-understand format.