Good Drug Regulatory Practices : A Regulatory Affairs Quality Manual
Book Details
Format
Hardback or Cased Book
ISBN-10
1574910515
ISBN-13
9781574910513
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Sep 30th, 1997
Print length
440 Pages
Weight
1,157 grams
Product Classification:
Popular medicine & health
Ksh 36,000.00
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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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