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Combination Products Regulatory Challenges And Successful Product Development 1st Edition Smita Gopalaswamy

  • SKU: BELL-1125040
Combination Products Regulatory Challenges And Successful Product Development 1st Edition Smita Gopalaswamy
$ 31.00 $ 45.00 (-31%)

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Combination Products Regulatory Challenges And Successful Product Development 1st Edition Smita Gopalaswamy instant download after payment.

Publisher: CRC Press
File Extension: PDF
File size: 2.13 MB
Pages: 260
Author: Smita Gopalaswamy, Venky Gopalaswamy
ISBN: 9781420064469, 1420064460
Language: English
Year: 2008
Edition: 1

Product desciption

Combination Products Regulatory Challenges And Successful Product Development 1st Edition Smita Gopalaswamy by Smita Gopalaswamy, Venky Gopalaswamy 9781420064469, 1420064460 instant download after payment.

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.

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