Books Books

Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition

Member: $295.00 Nonmember: $395.00
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition

This book is currently out of stock. We apologize for any inconvenience. Order now and get the e-book version at no additional cost. The e-book will automatically be added to your order during checkout and can be accessed immediately. Your hardcover book will be shipped once back in stock.

>> View Table of Contents
>> Author Acknowledgments

This critical resource includes all the pharmaceutical and biologics chapters from RAPS’ four Fundamentals of Regulatory Affairs books, covering the US, EU, Canada, and international. This highly focused compilation looks in-depth at requirements throughout the product lifecycle, from R&D through postmarketing. It is an excellent guide to finding answers on pharmaceutical and biologics regulations, learning about the industry, and as a study tool for the RAC (Drug) Exam.

Here's what you get in the Fourth Edition:

Special Offer - Also available as an e-book

To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Discount is only available when purchasing both versions in the same transaction.

Studying for the RAC?

RAC Exam questions are updated after the Spring testing cycle every year to reflect current regulations, guidelines and practice. New examination content is added before the Summer testing cycle and covers regulations in effect as of 31 December of the previous year.

This fourth edition book is the most up-to-date version currently available for RAC preparation purposes. The next revised edition of Fundamentals of Pharmaceutical and Biologics Regulations is scheduled to be released May 2023. Important note: While the Fundamentals books contain information on Canadian regulations, there are no Canada-specific questions on the RAC exams.

Take a look at our RAC prep resources

Published by RAPS © 2021. Hardcover. Two Volumes. 1,524 pages. ISBN: 978-1-947493-69-8.

Add to Cart Add E-book to Cart

Discover more of what matters to you


News »