The good news is the eCTD format has built-in functionality that can help simplify and improve submission building and life-cycle management chores across all product lines. The caveat is, however, ...

The eCTD specifications define multiple requirements for the packaging and creation of submissions using XML files and lead to expedited regulatory life cycles as well as a reduction in ... is now ...

From January 2010, the eCTD (electronic Common Technical Document) format became compulsory for all electronic-only submissions via the Centralized Procedure. A recent EU survey revealed that 28% of ...

This four day webinar series (each day 3 hrs) will provide you with an in-depth review of the content and format requirements of the CTD/eCTD.

The guidance, effective 22 June 2012, will supersede an earlier 2003 draft guidance entitled, "Preparation of New Drug Submission in the CTD Format. Read more: Guidance Document: Preparation of Drug ...

DUBLIN, Aug. 29, 2019 /PRNewswire/ -- The 'eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada' conference has been added to Research ...