Certara is the largest and most comprehensive provider of model informed drug development (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. The company includes more than 130 Ph.D. and M.D. pharmacometric experts, working on thousands of key modeling and simulation projects on behalf of hundreds of global biopharm companies. Synchrogenix, Certara’s scientific and regulatory writing consultancy employs more than 100 full-time writers and a network of another 100 staff available to strategical support the full range of global regulatory submittal documents.
Justifying a model-based approach to the agency is both an art and a science. Successfully employing quantitative pharmacology models requires addressing specific challenges in each therapeutic area while satisfying the sponsor’s overall business objectives and constraints. Realizing the value of integrated models and regulatory writing requires the right group of people who can deliver this vision. Synchrogenix has successfully helped dozens of clients obtain drug approvals using this approach. Having technology-enabled pharmacometricians and strategic regulatory writers as part of a sponsor’s team will improve their chances of success. By harnessing the power of modeling and superior regulatory writing, Certara is reshaping the pharmaceutical industry’s approach to drug development.
