Key Regulatory Topics: eCTD

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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.

Who should use this publication?

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.