Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
United States: 1-888-708-7444 or 1-919-852-4685
France: +33 1 56 95 17 10
Germany: +49 89 45 10 300
United Kingdom: +44 (0) 114 292 2322
India: +91 984 500 6625
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Used by all of the top 10 global pharmaceutical companies, together with the U.S. Food and Drug Administration (F.D.A.) and other key regulatory agencies, the Simcyp® Simulator is the industry’s most sophisticated solution for assisting in dose selection and informing product labeling. It links in vitro data to in vivo ADME (absorption, distribution, metabolism, and execretion) and pharmacokinetic/pharmacodynamic (PK/PD) outcomes to help explore potential clinical complexities prior to human studies and support decision-making in drug development.
With the Simcyp Simulator, researchers can:
Conducting clinical trials incurs immense costs. Thus, technologies that change clinical trial practices represent a sea change in drug development. Sponsors and regulatory agencies routinely use physiologically-based pharmacokinetic (PBPK) modeling and simulation to manage clinical trials. Join the biosimulation revolution and see how the Simcyp Simulator can help your drug achieve regulatory success.