CMC Regulatory Compliance for Pharmaceutical Products

Get an introduction to pharmaceutical product development and the concomitant Chemistry, Manufacturing and Controls (CMC) requirements by regulatory agencies. As drug development moves from concept to commercialization, the breadth and depth of CMC information required in submissions increases in parallel. It is important to understand the level of CMC compliance expected. You examine the CMC elements of drug substance and drug product—and, in particular, which elements are required and in what detail—at each stage of development. You also survey FDA guidelines and Points to Consider.