Academic Regulatory Science B.Pharm VII BP707T Paid Access

Regulatory Affairs (Theory)

By Ashish Vishwakarma, Rohit Arora & Mohini

Regulatory affairs is the discipline through which a medicine is brought to market lawfully and kept on it safely. It sits at the meeting point of pharmaceutical science, law, and ethics, and it has become one of the largest professional fields open to a pharmacy graduate, particularly in India, whose pharmaceutical industry supplies medicines to much of the world. This book follows the prescribed BP707T syllabus unit by unit.
Category
Pharmaceutical Regulatory Affairs
Target Audience
B.Pharm Semester VII Students
Course
B.Pharm Semester VII (BP707T)
Edition
1st Edition
ISBN
978-81-688112-9-4
Pages
Comprehensive Guide

About This Book

This book is written for the student of the B.Pharm seventh-semester course in Regulatory Affairs (BP707T), and it follows the prescribed syllabus unit by unit. The book is built on a single conviction: that the rules of regulation are best learned through the reasons behind them. Almost every requirement in this subject was written in response to a real failure.

The chapters explain not only what the rules are but why they exist, and they keep the Indian regulatory frame and the major international systems side by side throughout, so that the reader can compare rather than memorize in isolation. The content is current to the developments of recent years, including the New Drugs and Clinical Trials Rules, 2019 and the most recent revision of the international good clinical practice guideline.

Keywords

Regulatory Affairs Drug Approval Clinical Trials Good Manufacturing Practices Good Clinical Practices Pharmacovigilance CDSCO FDA EMA New Drug Application BP707T B.Pharm

How to Cite

Vishwakarma, A., Arora, R., & Mohini. (2026). Regulatory Affairs (Theory) (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-688112-9-4

DOI: 10.66079/wiseleaf.regulatory-affairs-bp707t.2026

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