Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
>> View Table of Contents
The process of compiling your electronic Common Technical Document (eCTD) can be overwhelming, but—with RAPS’ on your side—you know that you’ll have a competitive advantage.
Featuring guidance documents from the International Conference on Harmonization, European Medicines Agency and the US Food and Drug Administration, Key Regulatory Topics: eCTD keeps you on the cutting edge of regulatory.
Newcomers and experienced regulatory professionals will find value in the eCTD guide. It provides a solid background in the basics of compiling your eCTD while also containing a wealth of information for experienced pros seeking answers to specialized questions.