The strategic expansion of Certara’s US Access practice provides clients with opportunities to confront increasing drug pricing and reimbursement challenges
PRINCETON, NJ – July 9, 2019 – Certara has formed a new practice area called Certara Global Health (CGH) to focus its technological expertise on helping to achieve equity in health for all people worldwide.
Certara Announces First Recipients of Certara-Monash University Industry Drug Development Fellowships
PRINCETON, NJ – June 25, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, and Monash University today announced the recipients of the inaugural Certara-Monash University Industry Drug Development Fellowships – Dr. Katrina Hui, Dr. Yu-Wei Lin, and Dr. Zheng Liu.
Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug
PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.
Certara Scientists to Highlight Model-informed Drug Development, PBPK, MBMA and QSP Progress at PAGE 2019
Certara is contributing to 28 sessions, showcasing modeling by its pharmacometricians, systems pharmacologists, and experts in pharmacoeconomics/health economics outcomes research
It is a multi-functional, cloud-based, 21 CFR Part 11 compliant platform for clinical pharmacology, pharmacometrics and clinical operations professionals.
Certara® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, announced today that it has appointed Dr. William F. Feehery as its new Chief Executive Officer (CEO) and a member of the Certara Board of Directors, effective June 3, 2019.
New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.
PRINCETON, NJ – Apr. 4, 2019- ANVISA, MHRA and PMDA join EMA, FDA, NMPA and TGA in expanding their Phoenix software licenses to evaluate drug regulatory submissions
PRINCETON, NJ – Mar. 13, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 […]