Eudravigilance Services

EudraVigilance.

How to expertly manage all of your data and connections.

Pharmaceutical companies holding or applying for a MA and sponsors of clinical trials in the EEA must be registered in the EudraVigilance database system.

We can create and manage your EudraVigilance account, update your organization’s data as needed, create and manage your affiliates and virtual affiliates, and manage your 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.

What our clients say about us.

Selected PV Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support