Fundamentals of Regulatory Affairs Series



Fundamentals of US Regulatory Affairs, 10th Edition

For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. Introducing the 10th edition of Fundamentals of US Regulatory Affairs, the cornerstone of a good regulatory library.

Navigate the complexities of the requirements and guidance's of healthcare product regulation in one comprehensive resource. What’s new in the book:

  • More than 50 subject matter experts contributed to provide updates through May 2017
  • More detail on topics like preclinical trials and Good Laboratory Practices, and clinical trials and Good Clinical Practices, breaking these subjects down by product lines
  • New chapters on traceability and supply chain, and biosimilars
  • Easy to use matrix of applicable laws and regulations by product and lifecycle stage, plus a useful glossary and detailed index
  • Convenient, fully searchable e-book available on updated e-book reader

Available Now

Coming August 2017:

  • Fundamentals of US Medical Device Regulations
  • Fundamentals of US 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. Also available, Fundamentals of International Regulations sector-specific series.

Titles 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 guidance's.

    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.

      2017-US-Fundamentals-webpage-US     EU Fundamentals of Regulatory Affairs - Order Now   Canadian Fundamentals of Regulatory Affairs - Order Now
    2017-Fundamentals-webpage-int (002)   Global Medical Device Regulation - Order Now Global Pharmaceutical Regulation - Order Now