Over the past two decades, regulatory agencies globally have increasingly embraced Certara’s software portfolio to enhance the drug development process.
Certara’s state-of-the-art modeling and simulation platforms, such as the Simcyp PBPK Simulator and Phoenix PK/PD Platform, have become essential tools for evaluating regulatory submissions. The US FDA and other international agencies use these platforms, often in place of time-consuming human trials, to establish safe and efficacious dosing for special populations, additional indications, and bioequivalent medications. In addition, Pinnacle 21, our clinical data management and automation suite, is trusted by the FDA and Japan’s PMDA to ensure that submissions adhere to formats such as SEND, SDTM, and ADaM.
Certara’s contributions have supported more than 250 drug label claims. Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
