New edition of professional society reference volume sets forth fundamentals of U.S. regulatory affairs for life sciences products.
NATICK, MA – November 1, 2009 – Clinivation, Inc. announced today the upcoming publication of a new professional society reference volume coauthored by clinivation thought leaders in the areas of U.S. market clearance operations and regulatory affairs.
The book entitled Fundamentals of U.S. Regulatory Affairs is published by the Regulatory Affairs Professional Society.
The chapter coauthored by clinivation thought leader Richard Morroney addresses the U.S. FDA’s regulatory agencies, pathways, laws, regulations, and guidance.
The book is coauthored by Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc.
About Fundamentals of U.S. Regulatory Affairs:
Fundamentals of Regulatory Affairs books are recognized and trusted as the essential reference guides for regulatory professionals. Developed by established regulatory experts, each Fundamentals book provides a comprehensive understanding of the most current regulatory requirements across product lines. They lay out complex regulatory information clearly and concisely, with easy-to-read charts and analysis.
The publications are used by more than a dozen universities as a required text, some of the largest healthcare organizations as a staple in each employee’s office, and RAC Exam takers as a key study tool.