Developing pharmacovigilance system and its quality system can tie up capacities and become a challenge. At Insuvia, we aim to help pharmaceutical companies overcome this faster, easier, and more cost effectively.
We have built our global / regional pharmacovigilance system and processes specifically adapting it to provide small and mid-sized pharmaceutical companies with a cost-effective full-service safety department as an outsourced solution.
Insuvia provides an end-to-end solution to handle all aspects of pharmacovigilance and safety management globally:
Pharmacovigilance System, Pharmacovigilance System Master File (PSMF) and regional Sub-Files
QPPV office, including QPPV and Deputy QPPV, as well as local QPPVs
EudraVigilance and XEVMPD (Article 57) obligations
Processing and reporting of Individual Case Safety Reports (ICSRs)
E2B and CFR21 compliant Safety Database
Global and local literature monitoring
Signal detection and management
Risk Management Plans (RMPs)
Risk Minimization activities (DHPC, educational materials)
Periodic Safety Update Reports (PSURs)
Pharmacovigilance and safety data exchange agreements
Pharmacovigilance audits and inspections