Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling

With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. "This first of its kind qualification by EMA regula ...