eCTD Publishing

Let JensonR+ take care of your eCTD publishing requirements.

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.

eCTD publishing

It is important to get eCTD publishing right, as this is the format the Competent Authority will receive the Marketing Authorisation Application in. Having a correctly published sequence can ensure faster market access, through successful validation and reducing the number of RFIs (questions from the Health Authority).

At JensonR+, our regulatory team has extensive experience in eCTD publishing using multiple software systems and can offer support at any stage of the product lifecycle for various regional specifications.

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