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A TEXTBOOK OF REGULATORY AFFAIRS (M.PHARM) SEM I

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Book Details

  • Publisher: PV Books

  • Language: English

  • Course: M.Pharmacy / Semester I

  • ISBN: 9781543344530

About the Book

This textbook is prepared in accordance with the M.Pharm Semester I syllabus and provides a comprehensive understanding of Regulatory Affairs in the pharmaceutical sector. It covers regulatory frameworks, drug approval processes, documentation and submissions, quality standards, compliance requirements, and the roles of national and international regulatory authorities. The content is presented in a clear, systematic, and student-friendly manner to help postgraduate students understand the regulatory lifecycle of pharmaceutical products. The book is highly useful for regular study, revision, research orientation, and semester examination preparation for M.Pharmacy students.