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Distributed by Ingram and Baker & Taylor
Also available from
Amazon.com
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About the
Author
John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. He is a frequent speaker at corporate workshops and industry conferences, meets regularly with FDA officials, and his clients regularly achieve FDA approval.
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In a world where 83% of new medicines never make it to market, Get to Market Now! provides practical strategies to help you and your company tap into the secrets of successful new product development and the compliance structures to match. This book teaches you how to take advantage of evolving FDA compliance requirements and cutting-edge new product development techniques to bring your new medicine to market faster, easier, for less cost and less risk.
At the heart of the book, a systemic, structured new medicinal product development process — from discovery and preclinical through the postmarket stages — and a regulatory compliance and quality system designed to enhance business flexibility and encourage innovation.
Get to Market Now! shows you how to:
- Build safety, efficacy, and patient needs into your medicine from day one
- Set up a cost-effective quality system to maximize flexibility
- Get the right suppliers, professional services, and other help
- Use technology to minimize risk
- Protect yourself from regulatory enforcement
- Use links to the book.s exclusive web site.packed with valuable forms, checklists, and other resources
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