Fundamentals of Regulatory Affairs Series

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Fundamentals of US Regulatory Affairs, Ninth Edition

Fundamentals of US Regulatory Affairs is the definitive guide to regulatory requirements for healthcare products in the US. Order the new Fundamentals of US Regulatory Affairs, Ninth Edition now to make sure your regulatory library is up-to-date with expert information on the most current regulatory laws and guidances.


  • 41 chapters by 49 expert authors
  • Enhanced matrix that clearly explains current regulations
  • New chapters on regulatory strategy, regenerative medicine and user fees
  • 616 pages, hardcover

Books in RAPS' Fundamentals series are used by more than a dozen universities as a required text, in some of the largest healthcare organizations as a staple in each employee's office, and as a key preparatory resource for RAC Exam takers.

Available now:

Fundamentals of EU Regulatory Affairs, Seventh Edition

Breaking down the complexities of EU regulations and directives, Fundamentals of EU Regulatory Affairs provides a comprehensive review of human and veterinary medicinal products, biologics, medical devices, cosmetics and food supplements, as well as the applicable international standards and guidances.

The new edition covers:

  • 33 chapters by 38 expert authors from around the world 
  • Enhanced matrix that clearly explains current regulations 
  • New chapters on EU falsified medicines directive and regenerative medicines
  • Completely new chapters reflecting the changes in medical device regulations

Here is a free sample of what the new Fundamentals has to offer. 

Available now:

  • Hardcover edition
  • E-book edition
  • Bundle including both hardcover and e-book edition  

  • Entire Fundamentals of Regulatory Affairs Series

    The Fundamentals series provides a global perspective on regulatory practices, with books on Canada, EU and the rest of the world, as well as publications focused on pharmaceuticals, biologics and medical devices.