Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device IndustriesISBN: 978-0-470-55235-3
Hardcover
296 pages
May 2011
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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 .
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