Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual

1st Edition

Helene I. Dumitriu

CRC Press
Published September 30, 1997
Reference - 440 Pages
ISBN 9781574910513 - CAT# PH0515

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Summary

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.

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