Acknowledgments
Introduction
Part I: The Setup
Chapter 1: Today’s Regulatory Landscape
Chapter 2: Today’s New Drug, Biologic and Device Development Landscape
Chapter 3: Today’s Quality Systems and Regulatory Compliance Landscape
Chapter 4: Larger Landscape Trends Impacting Compliance and New Medicine Development
Part II: The Framework and Strategies
Chapter 5: Improving Innovation
Chapter 6: Building in Quality and Flexibility from Day One
Chapter 7: Designing the Lean Quality System
Chapter 8: Ensuring Lean Regulatory Affairs
Chapter 9: Driving a Holistic Regulatory Framework
Conclusion: Bringing It All Together
Appendix One: List of Acronyms
Appendix Two: Further Resources
