Pharmacovigilance

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

Adverse reaction may be reported using the following contacts:

Email: pv@eletis.lt

Tel. +370 37 370054

Fax: +370 37 370067