CTD

The conventional paper-based dossier

When you submit a conventional paper-based dossier, you have to structure your marketing authorisation documents according to the ICH regulations – as implemented in the European CTD specifications. It may also be necessary to rework older dossiers compiled according to the former NtA specifications. 

The submission of extensive documents to the various authorities on a tight time schedule demands a logistical masterpiece on your part. Our highly experienced specialists will be glad to help and advise.

Non-electronic CTDs are no longer possible

You have to bear in mind that the submission of “paper-only” dossiers is no longer a feasible option for most marketing authorisation procedures. We recommend that you secure the support of our highly skilled e‑Submission team at the earliest possible stage.