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The Pharmaceutical Regulatory Process
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The Pharmaceutical Regulatory Process Hardcover - 2008

by Ira R. Berry (Editor); Robert P. Martin (Editor)


From the publisher

Includes bibliographical references and index.

Details

  • Title The Pharmaceutical Regulatory Process
  • Author Ira R. Berry (Editor); Robert P. Martin (Editor)
  • Binding Hardcover
  • Edition International Ed
  • Pages 490
  • Volumes 1
  • Language ENG
  • Publisher CRC Press, New Delhi
  • Date 2008
  • Illustrated Yes
  • Features Bibliography, Illustrated, Index, Table of Contents
  • ISBN 9781420070422 / 1420070428
  • Weight 1.7 lbs (0.77 kg)
  • Dimensions 9.1 x 6.1 x 1.2 in (23.11 x 15.49 x 3.05 cm)
  • Library of Congress subjects Pharmacy - Law and legislation - United, Drugs - Law and legislation - United States
  • Library of Congress Catalog Number 2008042661
  • Dewey Decimal Code 344.730

About the author

IRA R. BERRY is President and Founder of International Regulatory Business Consultants, L.L.C., Freehold, New Jersey, USA. Ira Berry received his M.A. in Biology from Hofstra University, Hempstead, New York, USA and his M.B.A. in Management from Adelphi University, Garden City, New York, USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations, quality systems, compliance, regulatory affairs and business development--for APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance, quality systems evaluation, SOPs, preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcare's first edition of The Pharmaceutical Regulatory Process, as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.

ROBERT P. MARTIN is a consultant at RPMartin Consulting, Lebanon, Pennsylvania, USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California, Riverside, California, USA. Throughout his career, he has held positions at many pharmaceutical companies, including Forest Laboratories (as Associate Director of Quality Assurance), Duramed Pharmaceuticals (as Director of Quality Services), Merck & Co. (as Senior Scientist), and Johnson & Johnson (in several positions, including Manager of Quality Services). In these positions, he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm, he currently provides an array of pharmaceutical consulting services, including, such as vendor risk analysis and management, bioanalytical and analytical laboratory qualification/validation, manufacturing qualification/validation, auditing, documentation, CMC preparation, DMF preparation, and training.

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The Pharmaceutical Regulatory Process (Volume 185)
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The Pharmaceutical Regulatory Process (Volume 185)

by Berry, I. R. and Martin, R. P. (eds)

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Hardcover
ISBN 13
9781420070422
ISBN 10
1420070428
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Informa, 2008. Volume 185. This is an ex-library book and may have the usual library/used-book markings inside.This book has hardback covers. Clean from markings. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,850grams, ISBN:9781420070422
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The Pharmaceutical Regulatory Process, Second Edition (Drugs and the Pharmaceutical Sciences)
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The Pharmaceutical Regulatory Process, Second Edition (Drugs and the Pharmaceutical Sciences)

by Editor-Ira R. Berry; Editor-Robert P. Martin

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Informa Healthcare, 2008-12-02. Hardcover. Good.
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Pharmaceutical Regulatory Process 2nd edn
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Pharmaceutical Regulatory Process 2nd edn

by Berry, Ira R & Robert P Martin

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Pharmaceutical Regulatory Process 2nd edn
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Pharmaceutical Regulatory Process 2nd edn

by Berry, Ira R & Robert P Martin

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ISBN 13
9781420070422
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Pharmaceutical Regulatory Process 2nd edn
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Pharmaceutical Regulatory Process 2nd edn

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ISBN 13
9781420070422
ISBN 10
1420070428
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Pharmaceutical Regulatory Process 2nd edn
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Pharmaceutical Regulatory Process 2nd edn

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ISBN 13
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ISBN 10
1420070428
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The Pharmaceutical Regulatory Process, Second Edition
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The Pharmaceutical Regulatory Process, Second Edition

by Berry, Ira R./ Martin, Robert P.

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ISBN 13
9781420070422
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