How to expertly manage all of your data and connections.
Pharmaceutical companies holding or applying for marketing authorization (MA) and sponsors of clinical trials in the European Economic Area (EEA) must be registered in the Eudravigilance database system.
We will create and manage your Eudravigilance account, update your organization’s data as needed, create and manage your affiliates and virtual affiliates, and manage your Eudravigilance users.
We can also help you setup your gateway transmission to connect with EMA and perform regulatory submission of ICSRs directly, using either our Veeva Safety Vault system or your existing safety database.
We will guide you through the whole Eudravigilance set-up process and manage the transfer of the QPPV and/or Responsible Person functions from previous providers, as needed.