eCTD submission: Regulatory and Procedural Guidance

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It is an immense improvement over spending hours in a file room digging through files, taking out volume after volume just being able to pull up a 2-year-old investigational new drug (IND) application and look at it in a current view as well as a historical view in a few clicks. The secret to this significant change is the Popular Electronic Common Technical Document (eCTD), which represents a major advance in the global march towards electronic regulatory submissions. The eCTD defines how electronic submissions are to be made, reviewed and archived by the International Conference on Harmonization (ICH) back in 2003.


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