Regulatory Affairs in the Pharmaceutical Industry by Javed Ali [Paperback]

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.

Price: 128 GBP

Location: Gloucester

End Time: 2025-01-05T22:02:01.000Z

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EAN: 9780128222119

UPC: 9780128222119

ISBN: 9780128222119

MPN: N/A

Book Title: Regulatory Affairs in the Pharmaceutical Industry

Item Length: 27.9 cm

Item Weight: 0.67 kg

Number of Pages: 286 Pages

Language: English

Publication Name: Regulatory Affairs in the Pharmaceutical Industry

Publisher: Elsevier Science Publishing Co INC International Concepts

Publication Year: 2021

Subject: Medicine, Pharmacy, Management, Business

Item Height: 229 mm

Type: Textbook

Author: Sanjula Baboota, Javed Ali

Item Width: 152 mm

Format: Paperback