Pharmacovigilance and vigilance of medical devices
We offer performance of pharmacovigilance and vigilance services with qualified and professional personnel.
Pharmacovigilance services include a local contact person for pharmacovigilance with 24-hour availability, collecting and reporting of suspected adverse effects of medicinal products, maintenance of the pharmacovigilance system, preparation and maintenance of Standard Operating Procedures (SOP), communication with the competent authority and our partners, reviewing nationally prescribed literature, preparation of applications for review of educational materials (within the risk-management plan (RMP)) and preparation of DHPC.
Within the context of vigilance services for medical devices, we provide a local contact person for pharmacovigilance with 24-hour availability, communication with the competent authority (reporting to the competent authority on incidents with the medical devices) and notification of customers in case of field safety notices and incidents with the medical devices.
Reporting of suspected adverse events
+386 31 685 085