Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners

By Ajay G Pise, Ketki S Ande, Sandhya M Bagde

"Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners" is an exhaustive resource that aims to bridge the gap between academic curricula and industry requirements in the pharmaceutical domain. The book is carefully crafted to serve as a comprehensive guide for students, academicians, and professionals seeking to master the intricacies of regulatory writing and documentation practices. It provides a thorough understanding of the key aspects of documentation, including regulatory dossiers, SOPs, validation protocols, and clinical trial documentation, as well as international regulatory guidelines from the FDA, EMA, and ICH. The book also places special emphasis on practical aspects, incorporating real-world examples, case studies, and checklists to provide a hands-on learning experience and facilitate application in professional scenarios.

• Format: Hardcover
• Language: English
• ISBN: 9349562472
• ISBN13: 9789349562479
• Release Date: November 2025
• Publisher: Pharmamed Press
• Length: 152 Pages
• Weight: 0.82 lbs.
• Dimensions: 0.4" x 6.0" x 9.0"