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PRACTICAL HANDBOOK OF DRUG REGULATORY AFFAIRS-I

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Book Details

  • Publisher: PV Books

  • Author: Dr. Dilpreet Singh

  • Language: English

  • Course: M.Pharmacy / Semester I

  • ISBN: 9781543347616

About the Book

This practical handbook is prepared in accordance with the M.Pharm First Semester syllabus and is designed to provide hands-on exposure to Drug Regulatory Affairs-I. It focuses on practical aspects of regulatory documentation, submission processes, regulatory guidelines, and compliance requirements followed in the pharmaceutical industry. The content helps students understand real-world regulatory practices, dossier preparation, and the role of regulatory affairs in drug development and approval. Presented in a clear, systematic, and postgraduate-oriented manner, the book is highly useful for practical training, revision, research orientation, and semester examination preparation for M.Pharmacy students.