* Fundamentals of US Regulatory Affairs, 10th Edition available July 2017. Knowledge is the driving force of success in regulatory. Whether you are navigating the world of the US Food and Drug Administration or working in pharmaceuticals, biotech or medical devices, you need access to the most up-to-date information in your field. With new and updated content on everything from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement, this all-in-one reference book has you covered. The ninth edition features the experience and analysis of 49 authors in 41 chapters, and includes an updated matrix listing all pertinent laws and regulations as well as numerous tables, figures and other visual aids. It also includes three new chapters covering essentials such as regulatory strategy, stem cell technology and user fees. This new and innovative edition is the definitive guide to all US regulatory matters. RAPS and its expert authors have gathered all the information for you to continue your success and regulatory excellence.

Fundamentals of US Regulatory Affairs Ninth edition

RAPS

Regulatory Affairs Professionals Society (RAPS)

This book is an indispensable resource for professionals at all levels providing a comprehensive examination of applicable directives, regulations and national laws across the lifecycle for all product lines in the EU. It is also a valuable study tool for those preparing for the EU RAC exam.Regulatory students: Ask you professor about special RAPS pricing on the Fundamentals series.RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.

Fundamentals of EU Regulatory Affairs, Sixth Edition

Science & Math

Biological Sciences

RAPs

Very Good Condition. Used text for one semester in clinical research program and it was brand new when I purchased it. Some highlighting and underlining (shown in photos). Great price compared to other sites!!

Fundamentals of US Regulatory Affairs, Eighth Edition

Regulatory Affairs Professionals Society

This one-of-a kind publication is the most comprehensive reference for those working within the Canadian regulatory environment.  It covers established regulatory requirements across all product lines, throughout the product lifecycle. It breaks down complex Canadian regulations into a concise, highly readable format, clearly delineating the differences between US and Canadian regulations.This edition has expanded information on natural health products; human cells, tissues and organs for transplantation; Good Laboratory Practice; subsequent entry biologics; and new substances notifications.Take advantage of the comprehensive reference matrix to get to the information you need more quickly.Regulatory students: Ask you professor about special RAPS pricing on the Fundamentals series.RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.

Fundamentals of Canadian Regulatory Affairs, Third Edition

The second edition of Global Medical Device Regulation is a compilation of chapters covering medical device regulation in all major markets, adapted from the five books in RAPS' Fundamentals of Regulatory Affairs series. This single publication captures essential, broadly applicable regulatory information and concepts as well as compares and contrasts requirements in key global markets.
This book can be used as a single source of information on medical device regulations in the US, EU, Canada and Japan, as well as the international arena, based largely on Global Harmonization Task Force and ISO requirements. The publication dates for the individual books from which these chapters are drawn are: Fundamentals of US Regulatory Affairs ©2013; Fundamentals of International Regulatory Affairs ©2013; Fundamentals of International Regulatory Affairs ©2014; Fundamentals of EU Regulatory Affairs ©2012; Fundamentals of Japanese Regulatory Affairs ©2010.

RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.

Global Medical Device Regulation

This 11th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through April 2019. The content in this edition is more detailed than in the past and includes a new chapter on the master protocol.

Fundamentals of US Regulatory Affairs

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