Regulatory Affairs in the Pharmaceutical Industry: A Comprehensive Guide

Regulatory Affairs in the Pharmaceutical Industry is a detailed 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).

Key Topics Covered

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.

Updated Reference on Drug Approval Processes

This comprehensive guide provides updated reference on drug approval processes in key global markets. It offers comprehensive coverage of concepts and regulatory affairs, presenting a concise compilation of the regulatory requirements of different countries. It also introduces the fundamentals of manufacturing controls and their regulatory importance.

Author

Authored by Javed Ali, this book is a must-have for professionals in the pharmaceutical industry, regulatory affairs, and related fields.

Publication Details

Published by Elsevier Science, the book was released on November 14, 2021. It is available in English and has an ISBN of 9780128222119 and 9780128222232.