As your reliable out/in-sourcing partner, we are here to monitor the safety of your medicine.
We have been advising and supporting domestic and foreign companies in pharmacovigilance for over a decade.
Operating as a link between manufacturer, MAH, and Health Authorities making sure you have a pharmacovigilance system in place according to local needs.
We are here to assist you whether you need specific service or full PV support.
We provide a range of pharmacovigilance services such as:
- Handling ICSR (domestic & foreign)
- Handling periodic reports
- Compilation of PV data/dossier
- Monitoring daily incoming communication
- Tracking of reporting activities
- Preparing education material for distribution
- Tracking RMPs and planning for Regulatory submissions
- Implementation PV clause
- Training of local PV and non-PV staff
- Medical literature screening
- Monitoring local websites
- Periodic reconciliations
- QC vendor
- Case writing
- Categorization of cases
- Digitalization of individual segments