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(Ebook) Guidebook for Drug Regulatory Submissions by Sandy Weinberg ISBN 9780470371381, 9780470456170, 0470371382, 0470456175

  • SKU: EBN-1127524
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Instant download (eBook) Guidebook for Drug Regulatory Submissions after payment.
Authors:Sandy Weinberg
Pages:387 pages.
Year:2009
Editon:1
Publisher:Wiley
Language:english
File Size:5.5 MB
Format:pdf
ISBNS:9780470371381, 9780470456170, 0470371382, 0470456175
Categories: Ebooks

Product desciption

(Ebook) Guidebook for Drug Regulatory Submissions by Sandy Weinberg ISBN 9780470371381, 9780470456170, 0470371382, 0470456175

Destined to become every regulatory director's essential desktop companionrofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.
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