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Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling
GlobeNewswire News Room· 2025-08-04 06:00
Core Insights - Certara, Inc. has received formal qualification from the European Medicines Agency (EMA) for its Simcyp® Simulator, marking it as the first company to achieve this for a PBPK modeling platform [1][2] - The qualification allows sponsors to use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk, streamlining the drug submission process [2][3] - The recognition reflects Certara's scientific leadership and innovation in biosimulation, which is increasingly prioritized in drug development [3] Company Overview - Certara accelerates medicine development through biosimulation software and services, serving over 2,400 clients including biopharmaceutical companies and regulatory agencies in 70 countries [4]