Before Marketing Authorization Application (MAA)
We offer
- EV Account Setup
- SDEA / PVSA / safety contracts development
- Literature search and Regulatory Intelligence strategy setup
- Signal detection strategy setup
- QPPV assignment
- PSMF creation and maintenance
- Global PV database and setup
During and after MAA
We offer
- PSMF updates
- Conduct of regular Literature search and Regulatory Intelligence
- Conduct of signal detection (case and aggregate level reports)
- ICSRs (EU and ROW) processing, medical assessment, submissions
- CPPV network setup
- ESI management
From MA until Product Launch
We offer
- Continuous service provision
- Inspection readiness
- PSUR / PBRER development
- Periodic QPPV teleconferences
After the Launch
We offer
- Continuous service provision
- CPPV network setup
- Conduct of local Literature search and Regulatory Intelligence
- RMiM effectiveness assessment
If you’re interested in learning how our PV services can be implemented in your program, get in touch with us.