Eletis Medica can offer the pharmacovigilance support in all Baltic countries, Lithuania, Latvia and Estonia.

Eletis Medica services:

  • Registration of the Marketing authorization holder (MAH) in EudraVigilance system;
  • Formulation of safety report and its transmission via the EudraVigilance system;
  • Periodic Safety Update Report (PSUR), including harmonization and submission
  • Risk Management Plan (RMP)
  • Generation of Pharmacovigilance System Master File (PSMF) and creation of Module 1.8.1 – Summary of the PV system
  • Writing and Maintenance of Client specific SOPs and Process Guidelines
  • Fully Operational PV Safety Database System & EMEA Certified QPPV

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