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 

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