eSubmission: eCTD and non eCTD electronic submission (Nees)
An e-Submission is any presentation of information in electronic format sent by the applicant to the regulatory agency, in support of applications for marketing authorizations, variations, extensions, etc..
Specifically, the eCTD is the electronic version of the Common Technical Document (CTD). The structure, folders and file names correspond to those of the CTD and its .xml structure allows for easy browsing of the dossier.
With regard to the management of the life cycle of pharmaceuticals, Di Renzo Regulatory Affairs avails itself of the EXTEDO eCTD Manager Suite, the software used by major regulatory agencies. This ensures full compatibility in the exchange of information between the company and agency.
As long as the e-Submission in e-CTD is not mandatory in all Member States, a transitional format called Non-eCTD electronic Submissions (NeeS) has been provided, which is accepted by national regulatory agencies. For applications in the NeeS format the same eCTD structure is used, which must be in conformity with the ICH Granularity Document. The name of the NeeS file must comply with the same name as the eCTD file.
Di Renzo Regulatory Affairs has the know-how and equipment to prepare dossiers in eCTD and NeeS format.
The services that Di Renzo Regulatory Affairs can offer in this area are as follows:
- Formatting the the dossier from paper to electronic format (eCTD and Nees)
- Creation of the dossier in electronic format (eCTD and Nees)
- Life cycle management of the dossier