BREG 6310
CMC Regulations of Pharmaceuticals

Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinationals with an increasing trend towards investment in rapidly developing but poorly regulated nations.(BCA 419)

Biocon Academy students only