Pharmaceutical Regulatory Science

Title
Pharmaceutical Regulatory Science

Authors / Editors

• Editor: Dr. Ravi Shankar Tripathi

• Co-Editor: Dr. Pravin Badhe

• Contributing Authors: Sushmita Hiremath; Nikhil Gawas; Bono Naga Sudha; Thokala Ujwala Reddy; Kanchanam AshaDeepthi; Shaik Shabana; Dr. Vivek R. Mallurwar; Reema Sanghvi; Dr. Sivakumar Kullampalayam Krishnasamy; Dr. Abinaya Mouralidasse; Yarra Sai Phanindra; Mrs. Kandregula Kesava Uma Maheswari

Publisher
Swalife Foundation (Biopress Division)

Publication Year
2025

ISBN
978-81-982382-3-8

Language
English

Abstract
Pharmaceutical Regulatory Science plays a vital role in ensuring the safety, efficacy, and quality of medicines. This volume—prepared under the Biopress Division of Swalife Foundation—provides a comprehensive yet practical overview of the global regulatory landscape for pharmaceuticals. Covered topics include:

• Drug Discovery & Development: Key stages and regulatory considerations

• Approval Pathways: From IND submissions to market authorization

• Regulatory Authorities & Agencies: Comparative overview (FDA, EMA, CDSCO, etc.)

• Overseas Registration: Strategies for Indian drug products in global markets

• Clinical Trials: Design, conduct, and ethical requirements

• Core Regulatory Concepts: Risk management, quality systems, labeling, and pharmacovigilance

Authored by leading academics and industry experts, this book supports students, researchers, and professionals seeking both foundational theory and hands-on guidance for navigating regulatory processes worldwide.

Keywords
Pharmaceutical; regulatory science; drug approval; clinical trials; global registration; pharmacovigilance; quality systems; IND; NDA; EMA; FDA; CDSCO

How to Cite
Tripathi, R. S., & Badhe, P. (Eds.) (2025). Pharmaceutical Regulatory Science. Pune, India: Swalife Foundation – Biopress Division. ISBN 978-81-982382-3-8.