TitlePharmaceutical 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 PublisherSwalife Foundation (Biopress Division) Publication Year2025 ISBN978-81-982382-3-8 LanguageEnglish VersionFinal LicenseCC BY-NC-ND 4.0 International AbstractPharmaceutical 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. KeywordsPharmaceutical; regulatory science; drug approval; clinical trials; global registration; pharmacovigilance; quality systems; IND; NDA; EMA; FDA; CDSCO How to CiteTripathi, R. S., & Badhe, P. (Eds.) (2025). Pharmaceutical Regulatory Science. Pune, India: Swalife Foundation – Biopress Division. ISBN 978-81-982382-3-8.