Good Drug Regulatory Practices : A Regulatory Affairs Quality Manual
Book Details
Format
Paperback / Softback
ISBN-10
0367448084
ISBN-13
9780367448080
Publisher
Taylor & Francis Ltd
Imprint
CRC Press
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Dec 2nd, 2019
Print length
440 Pages
Weight
227 grams
Dimensions
20.10 x 13.20 x 1.30 cms
Product Classification:
Biology, life sciences
Ksh 11,900.00
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This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). It covers regulatory affairs regarding global product development for the European Union, Japan, and the United States.
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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