Regulatory Affairs in the Pharmaceutical Industry (Paperback)

Regulatory Affairs in the Pharmaceutical Industry By Javed Ali (Editor), Sanjula Baboota (Editor) Cover Image
By Javed Ali (Editor), Sanjula Baboota (Editor)
$283.50
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Description


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 15th, 2021
Pages: 286
Language: English