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
Interested in Certara's biosimulation solutions? Want to speak to someone in our sales team? Click on the link below!
Physiologically-based pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry and genetics. We integrate this information with in vitro drug absorption, metabolism and transport data to simulate and predict pharmacokinetics in virtual patient populations. Such ‘population-based’ PBPK modeling is increasingly being used in regulatory review to facilitate decisions on the necessity for specific clinical studies, to inform study design and guide appropriate labeling language.
Certara is the leader in mechanistic pharmacokinetics with an international reputation for in vitro-in vivo extrapolation of drug absorption, distribution, metabolism and elimination (ADME) data. In addition to licensing the Simcyp Population-based Simulator, we offer consultancy services on all aspects of drug ADME and PK/PD data analysis and interpretation.
Certara can review and critique available pre-clinical ADME and physical chemistry data to ensure that they are fit-for-purpose. Together with the client, Certara personnel help design a PBPK modelling and simulation strategy to help answer a wide variety of clinical questions without having to resort to in vivo study. This service is ideally suited to those clients who do not have the resources or time to use our simulation technology directly. Certara offers a bespoke turn-key PBPK modeling and simulation (M&S) solution, including data review, project design, analysis, interpretation and report writing.
Here are just a few examples of where our Consultancy has helped clients:
Our experts can help you to construct a cumulative knowledgebase, accessible across your team for enhanced collaboration and decision making.