Good Drug Regulatory Practices : A Regulatory Affairs Quality Manual book cover
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1st Edition

Good Drug Regulatory Practices
A Regulatory Affairs Quality Manual




ISBN 9780367448080
Published December 2, 2019 by CRC Press
440 Pages

 
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Book Description

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in your company.

Table of Contents

Part I: The Regulatory Affairs Quality System 1. Historical Overview 2. Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs 3. Check Your Quality System Part II: The Regulatory Affairs Quality Manual 4. The Quality Manual Explained 5. The Philosophy behind the Policies 6. Policies 7. Standards

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Author(s)

Biography

Dumitriu, Helene I.