Creating unquestionable value for our partners is our #1 priority
Using modeling and simulation across the entire drug development life cycle, we help to de-risk your program, increase confidence in critical decisions, and help you reach your goals, smarter and faster. Acting as your dedicated stewards, our best-practice, quantitative systems and integrated approach delivers significant time and cost savings while accelerating regulatory and commercial success. From clinical pharmacology to pharmacometrics to regulatory submission and strategy and market access, we have 650+ leading experts throughout the world who are dedicated to achieving your goals. Build your drug development dream team with Certara.Contact the MIDD Dream Team
Since 2014, customers who use our biosimulation software and technology-driven services have received 90% of all new drug approvals by the U.S. Food and Drug Administration.
90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022, excluding diagnostic agents. This is the 9th consecutive year that Certara’s customers, who use the Company’s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases.
Regulators are on board with PBPK.
This means that the regulatory-accepted predictions from the Simcyp Simulator have enabled the sponsors of these 100 new drugs to add prescribing information to the drug label, thus eliminating costly and time-consuming clinical studies, while also expanding the potential patient population for that drug.