Submit your PSUR in eCTD format with eCTD247

Since June 2016, an EMA guideline states that marketing authorisation holders must submit E.U. Periodic Safety Update Reports (PSUR):

  • In eCTD or NeeS format
  • To the central PSUR repository, using EMA’s eSubmission Gateway / Web client

A simple and effective solution: eCTD247

eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time.

eCTD247 also:

  • Is the only online eCTD solution
  • Has a pricing based on the number of documents in your submissions.
  • Is very easy to use, with minimal training time to become efficient and start publishing and submitting your eCTD

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

All inclusive submission service

If you do not have the time to edit your eCTD PSUR by yourself, we can also propose you an all inclusive service for your PSUR submission.

Please refer to the web site or Contact us for more information. You will find a convenient FAQ that answeers all your questions regarding PSUR eCTD submissions.

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