Resources for Colleges and Universities

Fundamentals of Regulatory Affairs Series

Fundamentals 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 Regulatory Affairs Certification (RAC) Exam takers as a key study tool.

The Ideal Textbooks for Regulatory Courses

Developed by established regulatory experts, each Fundamentals book provides a comprehensive understanding of the most current regulatory requirements across product lines. They break down complex regulations into simple language, with versions for the US, Canada, EU and Japan, as well as an International edition.

We also offer Global Medical Device Regulations—a compilation of chapters covering medical device regulation, adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series.

Request a Sample E-Book Version of Fundamentals

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Edition Requested	US Canadian EU Japanese International
For University/College use only. Regulatory students may purchase Fundamentals for a special student membership rate.

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Universities that have used or recommended Fundamentals:

Arizona State University

Campbell University School of Pharmacy

Duke University

Grace College

Johns Hopkins University

Northeastern University

Regis College

Rutgers University

San Diego State University

UCSC Extension

University of California Santa Cruz

"The Fundamentals of EU Regulatory Affairs, Sixth Edition contains a unique combination of important industry topics that are vital to communicate to our students. The content is rich and presented through clear organization and a well-defined series of objectives covered in the book.

I strongly recommend this book to audience ranging from students to well-established industry professionals."

Yulia Perlman, MSc.Corp, adjunct graduate instructor at Northeastern University, College of Professional Studies

Resources for Colleges and Universities

Fundamentals of Regulatory Affairs Series

The Ideal Textbooks for Regulatory Courses

Request a Sample E-Book Version of Fundamentals

Universities that have used or recommended Fundamentals:

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