Village Books & Paper Dreams - Fairhaven
Mon-Sat: 9am-8pm
Sun: 10am-8pm
masks required
Village Books - Lynden
Mon-Sat: 10am-6pm
Sun: 12-4pm
masks required

Regulatory Affairs in the Pharmaceutical Industry (Paperback)

Pre-Order Now Badge
Regulatory Affairs in the Pharmaceutical Industry Cover Image
By Javed Ali (Editor), Sanjula Baboota (Editor)
Coming Soon - Available for Pre-Order Now


Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).

Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

Product Details
ISBN: 9780128222119
ISBN-10: 0128222115
Publisher: Academic Press
Publication Date: November 27th, 2021
Language: English