Comprehensive Guide to Regulatory Affairs in the Pharmaceutical Industry

Authored by Javed Ali, this book provides an in-depth look into the regulatory affairs currently practiced in the pharmaceutical industry. It aims to equip readers with advanced knowledge and skills required to understand various concepts of regulatory affairs, including 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

This comprehensive guide covers a wide range of topics, including 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.

Global Market Insights

Updated reference on drug approval processes in key global markets, this book provides comprehensive coverage of concepts and regulatory affairs. It presents a concise compilation of the regulatory requirements of different countries, introducing the fundamentals of manufacturing controls and their regulatory importance.

Why This Book?

With its comprehensive coverage of regulatory affairs in the pharmaceutical industry, this book is an essential resource for professionals and students alike. It offers insights into the regulatory processes, documentation, and approval processes, making it a valuable tool for those looking to advance their knowledge and skills in this field.