Fundamentals

Stay on top of today’s laws and regulations—by region and by product 

RAPS’ Fundamentals of Regulatory Affairs series puts all the information you need right at your fingertips. These books are not just for new regulatory professionals either. Each is designed to provide the basics across the full product lifecycle, with precise indexing to save you time and effort. If you work in regulatory in multiple markets or are learning about a new product line, Fundamentals makes life a lot easier. And if you are planning to take the RAC exam, they make a solid cornerstone to prepare.
 

US Fundamentals 11th edition
Fundamentals of US Regulatory Affairs, 11th edition 
Table of Contents

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Fundamentals of EU Regulatory Affairs,  Eighth edition 
Table of Contents

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Fundamentals of International Regulatory Affairs,  Fourth edition
Table of Contents

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Fundamentals of Canadian Regulations Bundle​
Table of Contents

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Medical Device Regulation Subsets

Purchase each subset individually or collectively, in a bundle. The bundle includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books: US, EU, Canada and International. 

Need to focus on medical devices or IVDs? No problem. You can buy subsets comprised of just the medical device and IVD chapters from each region—US, EU, Canada and International—individually or together as a bundle.

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Fundamentals of US Medical Device Regulations (e-book)
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Fundamentals of EU Medical Device Regulations
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Fundamentals of Canadian Medical Device Regulations
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Fundamentals of International Medical Device Regulations
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Pharmaceutical and Biologics Regulation Subsets

Purchase each subset individually or collectively, in a bundle. The bundle includes the individual pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books: US, EU, Canada and International.

Need to focus on drugs or biologics? No problem. You can buy subsets comprised of just the pharmaceutical and biologics chapters from each region—US, EU, Canada and International—individually or together as a bundle.

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Fundamentals of US Pharmaceutical and Biologics Regulations
(e-book)

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Fundamentals of EU Pharmaceutical and Biologics Regulations
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Fundamentals of Canadian Pharmaceutical and Biologics Regulations
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Fundamentals of International Pharmaceutical and Biologics Regulations
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