Pharmaceutical Pre-Approval Inspections, 2/E, Vol.181 (Ex): A Guide To Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)

Name: Pharmaceutical Pre-Approval Inspections, 2/E, Vol.181 (Ex): A Guide To Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)
SKU: 9780849391842
Availability: InStock

SKU: 9780849391842

Original price was: ₹2,995.00.Current price is: ₹2,396.00.

Navigate the complexities of FDA pre-approval inspections with “Pharmaceutical Pre-Approval Inspections, 2/E: A Guide To Regulatory Success.” This indispensable second edition from The Bookish Owl is your roadmap to achieving regulatory approval efficiently. It thoroughly covers modern FDA expectations, including the GMPs of the 21st Century, quality systems, risk-based approaches, Quality by Design, PAT, and design space. Understand the critical shifts in inspection methodologies, from research and development to training, and learn what inspectors expect at every stage. Essential for pharmaceutical professionals, this guide helps ensure a smooth transition for both domestic and international facility transfers, ultimately boosting your chances of rapid regulatory success.

5 in stock

Category: Higher Education Textbooks Tag: Martin D. Hynes