The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Focusing on practical strategies, this book offers insight into managing CMC regulatory compliance for biopharmaceuticals, emphasizing a common-sense business approach. It covers the entire lifecycle of biopharmaceutical products, from clinical development to post-market approval, while adapting to evolving regulations. The first chapter outlines the CMC regulatory process and the range of products involved, while the second chapter highlights the distinctions in regulatory treatment between biopharmaceuticals and chemically-synthesized drugs, underscoring the significance of CMC FDA.