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eCTD, or electronic common technical document – is the electronic format that a medicine dossier is required to be in for submission to a Health Authority when attaining a Marketing Authorisation.
All subsequent variations to the MA after approval, must also be submitted in this format. Breaking this down – the CTD (Common Technical Document) is the traditional 5 module hierarchy, whilst the eCTD cross-links these modules on an XML backbone. The eCTD is now an international standard that is followed to ensure effective transfer of regulatory information and simplifying the process of submission.