Certara, Inc.

Certara is a biosimulation and regulatory science technology company for the pharmaceutical, biotech, and academic research industries. Founded in 2008 in Princeton, New Jersey (building on capabilities developed over 20+ years by predecessor organizations), Certara uses mathematical modeling and simulation to predict drug behavior, optimize clinical trial design, and support regulatory submissions to agencies like the FDA and EMA.

The flagship software, Simcyp, is a population-based pharmacokinetic/pharmacodynamic modeling and simulation tool. It predicts how drugs will behave in diverse patient populations before clinical trials even start. Phoenix WinNonlin is the industry standard for pharmacokinetic analysis. D360 is a cloud analytics platform for drug development decisions. Together, these tools help pharma companies reduce the time, cost, and failure rate of drug development by supplementing physical experiments with virtual simulations. Instead of running another expensive clinical trial, a company can simulate the outcomes first and design a better study.

The regulatory science consulting division provides model-informed drug development services. That includes submission-ready analyses, clinical pharmacology strategies, market access analytics, and real-world evidence studies. Regulatory agencies themselves increasingly recognize this approach. The FDA uses Certara's Simcyp simulator internally, and model-informed methods are now encouraged in regulatory guidance.

About 2,100 customers use the platform, including all of the top 35 pharma companies by R&D spending, along with hundreds of biotech firms, CROs, and academic institutions. Annual revenue is roughly $400 million. Revenue mixes software subscriptions with technology-driven consulting. Software gross margins top 80%. About 1,600 employees work across offices in the US, Europe, and Asia.