In order to obtain new marketing authorizations for pharmaceuticals and to carry out the necessary updates to the registration dossiers through variation applications, soon the standard eCTD (electronic Common Technical Document) will be mandatory in all the European countries.

Di Renzo Regulatory Affairs possesses the expertise and the instruments to turn any kind of dossier from the old format into the eCTD (including old NTA dossiers).

In addition, it is able to manage the life cycle of the product by means of its regulatory/administrative, technical and clinical competence.