Main description:

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.

Contents:

PREFACE. Chapter 1. Controlling Regulatory Costs. Chapter 2. Clear Operation Definitions of Requirements. Chapter 3. Pre-Regulatory Audits. Chapter 4. Quality by Design. Chapter 5. Outsourcing. Chapter 6. Electronic Submissions. Chapter 7. EMEA/FDA Inspections. Chapter 8. Managing FDA Inspections. Chapter 9. Risk Assessment. Chapter 10. Cases. Chapter 11. Cost Containment Analysis. Chapter 12. Managing Regulation In Times of Chaos. Chapter 13. International Regulation. Chapter 14. Cost Contained Regulatory Compliance. Chapter 15. Future. BIBLIOGRAPHY. INDEX .