The EMA’s eCTD 4.0 pilot is entering its next stage, and Ennov is ready to support Marketing Authorization Holders (MAHs) who are participating.
Following our own successful test submission during the technical pilot phase (read more here), we are now prepared to help our customers during the customer pilot phase.
Ennov’s Regulatory platform is already aligned with EMA’s latest eCTD 4.0 specifications. For customers accepted into the pilot, we can provide the following:
Please note: Participation in this customer pilot is dependent on selection by EMA. MAH’s must submit their request and provide details of their proposed products, scenarios and very importantly the name of the eCTD v4.0 tool, by 15 July by email to [email protected]. Upon confirmation from EMA will send details on how the test packages can be submitted.
If your organization has been selected for the pilot and you are preparing to submit, our team is here to help.
