Risk Management

Risk management planning within pharmacovigilance has become a strategic part of drug development.

Submission of a Risk Management Plan (RMP) in the EU and, in the US, establishment of a Risk Minimization Action Plan (RiskMAP) as part of a Risk Evaluation and Mitigation Strategy (REMS) are critical elements in gaining marketing approval for your product. It is also an important requirement that you measure the impact of your risk minimization strategy and expedite any necessary changes.

By bringing together our pharmacovigilance and technical expertise we can help you develop your RMP/REMS and, with the aid of our smart Apps, speedily measure their effectiveness.