The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by John Geigert
Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval.
In summary, this book:
- Updates real-world CMC deficiency examples with current examples;
- Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;
- Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.