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Regulatory Consulting eCTD

An e-Submission is any presentation of information in electronic format sent by the applicant to the Competent Authority, to support applications for marketing authorizations (MAs), 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 with Competent Authorities.

Di Renzo Regulatory Affairs has the know-how and equipment to prepare dossiers in eCTD format. In particular, we can assist companies carrying out the following:

  • Formatting the dossier from paper to electronic format
  • Creation of the dossier in eCTD
  • Management of the dossier life cycle

Foto di Goumbik da Pixabay