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Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

John Wiley and Sons Ltd, May 2011, Pages: 296


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This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

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