Certara announces EMA qualification of Simcyp Simulator

Certara (CERT) announced that the European Medicines Agency has formally qualified the Simcyp Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA. With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction risk without needing to re-establish the platform’s credibility for the specified context of use scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies