Global Regulatory Systems: A Strategic Primer
Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration brings global regulatory systems together in one practical framework. The book is designed to help readers develop a coordinated, proactive, and systematic approach to global product development and registration, with the broader goal of supporting expedient access to important medicines.
For regulatory professionals, product-development teams, students, and biopharmaceutical leaders, the book provides a foundation for understanding how regulatory strategy can be integrated across regions rather than approached as a series of disconnected submissions.