Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual, 1st Edition (Hardback) book cover

Good Drug Regulatory Practices

A Regulatory Affairs Quality Manual, 1st Edition

By Helene I. Dumitriu

CRC Press

440 pages

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Hardback: 9781574910513
pub: 1997-09-30
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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.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology