The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
- 367 pages
- 13 hours of reading
This book addresses the challenges of quality assurance/quality control (QA/QC) in the biopharmaceutical sector, emphasizing its strategic value in manufacturing. It discusses the need for a graded QA/QC approach from clinical trials to market approval and includes updates on new regulatory guidances and the development of biosimilars and other biologics.
