Responsible Person services

Responsible Person services.

Why you need a Responsible Person for Eudravigilance and the EEA?

The EudraVigilance registration process requires the appointment of a Responsible Person for EudraVigilance for all clinical trial sponsors who are not a Marketing Authorization Holder (MAH), or Marketing Authorization Applicant (MAA), to act as their organization’s representative .

We can provide you with an experienced standalone Responsible Person allocated to your project and for all your clinical trials conducted in the EEA.

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

What our clients say about us.