Science/Engineering Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (3764383615)

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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

At last! The book for anyone who writes regulatory documents or wishes to learn more about writing regulatory documents for the biopharmaceutical industry. Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics, written by 2 well-known regulatory writers with a combined 40 years experience, provides detailed information on ‘targeted’ writing. Many books, papers, and Web sites provide information on what needs to be written and submitted to regulatory authorities, but this comprehensive book shows you how to approach the writing task in a logical process that permits rapid completion of writing.Targeted Regulatory Writing Techniques is the first comprehensive book of regulatory writing for the biopharmaceutical industry, and covers specific documents types, as well as submission to all major regions of the world. The book provides a ‘targeted’ method of document development -- a way of planning for information flow that maximizes efficiency and speed to submission. The book has a hands-on approach to identifying methods that quickly determine which document is required, how to write it, and how it fits into submission types. The authors share their experiences with numerous ‘Lessons Learned’ side bars of information.

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	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (2008) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and BiologicsPublisher: Informa HealthCare \| English \| ISBN: 1420073540 \| 464 pages \| 2008 \| PDF \| 6 MbDescription: Examines harmonization of the US Federal Food, Dr ...
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	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition: Douglas J. Pisano, David S. Mantus Informa HealthCare \| ISBN: 1420073540 \| August 11, 2008 \| PDF (OCR) \| 464 pages \| 7911 KB Examines h ...
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	Technical Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (Re-post) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (Re-post) Publisher:Birkhäuser Basel \| Pages:237 \| 2008-12-05 \| ISBN:3764383615 \| PDF \| 1.8 MBAt last! The book for anyone who writes regulatory documents ...

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	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (2008) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and BiologicsPublisher: Informa HealthCare \| English \| ISBN: 1420073540 \| 464 pages \| 2008 \| PDF \| 6 MbDescription: Examines harmonization of the US Federal Food, Dr ...
	Study Targeted Cancer Therapy (Current Clinical Oncology) Targeted Cancer Therapy (Current Clinical Oncology) Publisher: Humana Press \| ISBN: 1603274235 \| edition 2008 \| PDF \| 550 pages \| 6,3 mbEmerging technologies in target identification, drug discovery, molecular markers, and imaging are rapi ...
	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition: Douglas J. Pisano, David S. Mantus Informa HealthCare \| ISBN: 1420073540 \| August 11, 2008 \| PDF (OCR) \| 464 pages \| 7911 KB Examines h ...
	FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug appr ...
	Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives (Drugs and the Pharmaceutical Sciences) Author: Publisher: Informa HealthCare (2006)Binding: Hardcover, 360 pagespricer: $199.95ISBN-10: 0824725387editorialreviewsThe international popularity of herbal remedies has recently outpaced quality information on the utilization and dosi ...
	Technical Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (Re-post) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (Re-post) Publisher:Birkhäuser Basel \| Pages:237 \| 2008-12-05 \| ISBN:3764383615 \| PDF \| 1.8 MBAt last! The book for anyone who writes regulatory documents ...

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