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
- 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 software, 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 eCTD247.com web site or Contact us for more information. You will find a convenient FAQ that answeers all your questions regarding PSUR eCTD submissions.