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(Ebook) Combination Products: Regulatory Challenges and Successful Product Development by Smita Gopalaswamy, Venky Gopalaswamy ISBN 9781420064469, 1420064460

  • SKU: EBN-1125040
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$ 32 $ 40 (-20%)

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4.5

31 reviews
Instant download (eBook) Combination Products: Regulatory Challenges and Successful Product Development after payment.
Authors:Smita Gopalaswamy, Venky Gopalaswamy
Pages:260 pages.
Year:2008
Editon:1
Publisher:CRC Press
Language:english
File Size:2.13 MB
Format:pdf
ISBNS:9781420064469, 1420064460
Categories: Ebooks

Product desciption

(Ebook) Combination Products: Regulatory Challenges and Successful Product Development by Smita Gopalaswamy, Venky Gopalaswamy ISBN 9781420064469, 1420064460

The field of combination product development is so new that very few publications, including FDA documents, are available. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement these products into the market successfully and in a timely manner.
*Free conversion of into popular formats such as PDF, DOCX, DOC, AZW, EPUB, and MOBI after payment.

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