Marketing Authorization Application

To support a Marketing Authorization (MA), the sponsor should submit the medicine’s electronic Common Technical Document (eCTD) dossier to the European Medicines Agency (EMA) or the National Competent Authorities (NCA).

How can DDR help?

  • DDR will support companies at every stage of the Marketing Authorization Application (MAA), from pre-submission activities and agencies’ interactions up to final submission.
  • DDR will oversee the entire procedure and continue to manage the MAA throughout the assessment phase until the authorization is complete; this includes providing assistance in potential oral explanations.
  • DDR will provide a network of experts who will guide and assist the companies through the writing, preparation and revision of each of the eCTD modules.
  • DDR will give advice and regulatory support at the time of answering the
  • EMA or NCA questions, if required.
  • DDR will assist in the preparation of the re-examination process and the organization of a possible oral explanation with the EMA or the corresponding NCA, if required.

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