Strategic Consulting and Advisory Services
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.
Software Portfolio: 'End-to-end' Modeling
Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
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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.
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Japanese Regulatory Agency Licenses Certara’s Phoenix and Simcyp Software
February 26, 2015
Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s biosimulation software
PRINCETON, NJ – Feb. 26, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator. PMDA joins FDA and several other global regulatory agencies in increasing its reliance on biosimulation for investigational new drug and new drug approval reviews.
“Biosimulation is now consistently relied upon by regulatory agencies’ pharmacometrics teams in pre-clinical, clinical and post-approval drug development decisions,” said Certara CEO Edmundo Muniz, M.D., Ph.D. “Furthermore, a paper and survey from the International Consortium for Innovation and Quality in Pharmaceutical Development published by the American Association of Pharmaceutical Scientists last month stated that Phoenix was used by 100 percent of the 22 leading pharmaceutical companies surveyed, and 86 percent of them were using Simcyp. These percentages placed Certara’s offerings as the #1 and #2 ranked biosimulation solutions. We are proud to be working with PMDA, as it advances the use of these innovative modeling approaches from regulatory science to regulatory approval.”
PMDA is using PPK (population pharmacokinetic), PK/PD (pharmacokinetic/pharmacodynamic), and other modeling and biosimulation approaches for dosage, dose regimen and dose adjustment for special populations, including pediatrics. In addition, PKS Online will provide the technical infrastructure necessary to securely store and manage PK and PD study data, and the associated pharmacometric analyses, in a regulatory-compliant environment.
Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for the prediction of drug-drug interactions, assisting in dose selection, and informing clinical decisions related to product labeling. Simcyp whole body simulation methodology can predict the pharmacokinetics of drug compounds and proteins based on in vitro data. The Simulator includes a unique set of genetic, physiological and epidemiological databases that facilitate the simulation of virtual populations from around the globe.
In addition to PMDA, all leading Japanese pharmaceutical companies have integrated both the Phoenix and Simcyp biosimulation solutions into their drug development workflow.
About Certara
Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.
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Rana Healthcare Solutions
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