RA & PV

Eumedica | Regulatory Affairs & Pharmacovigilance | What We Do

WHAT WE DO

In a fast-moving environment that is subject to increasingly stricter international regulations, Eumedica offers all the regulatory, pharmacovigilance and scientific support you need for your pharmaceutical products and medical devices. We offer the following RA & PV services:

  • Pre-marketing RA with preparation and submission of applications for pharmaceutical products and medical devices
  • Post-marketing RA with follow-up and maintenance of applications for pharmaceutical products and medical devices
  • Main interface between customer and local competent authorities
  • Marketing Authorisation Holder (MAH) upon request
  • International network with focus on United Kingdom, France and BeNeLux
  • Pre- & post-marketing pharmacovigilance services including EU-QPPV and local representatives in EU
  • Monitoring of product safety through signal management, PSUR/PBRER and RMP
More info about our RA & PV services