Fundamentals of Regulatory Affairs Series


Introducing the new Fundamentals of International Regulations sector-specific series. 

The Fundamentals of International Regulations sector-specific series is derived from the third edition of Fundamentals of International Regulatory Affairs. Each volume focuses on requirements for either medical devices or pharmaceutical and biologics. Now, you can choose exactly what you need—on the topic that pertains to you. 

Titles Available Now:

More to Come in 2017:

  • Fundamentals of US Medical Device Regulations
  • Fundamentals of US Pharmaceutical & Biologics Regulations
  • Fundamentals of EU Medical Device Regulations
  • Fundamentals of EU Pharmaceutical & Biologics Regulations


Fundamentals of International Regulatory Affairs, Third Edition

This third edition is updated with developments through 2016 and delves more deeply into specific countries and regions than previous editions. It covers the full gamut of regulated healthcare products.

    Available Now


    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 now to make sure your regulatory library is up to date with expert information on the most current regulatory laws and guidances.

      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.

      Available Now


      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.