New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.
Global Regulatory Agencies Increase Adoption of Certara’s Phoenix PK/PD Modeling and Simulation Software for Drug Regulatory Reviews
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 […]
Certara Showcases Multi-faceted Approach to Improving Drug Safety Assessments at the Society of Toxicology Annual Meeting
PRINCETON, NJ – Mar. 8, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that it will be showcasing its multi-faceted – technology, service and regulatory science – approach to improving new drug safety assessments at the Society of Toxicology (SOT) Annual Meeting and […]
Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems
PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
PRINCETON, NJ – February 21, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the launch of version 19.1 of its flagship scientific informatics platform D360.
PRINCETON, NJ – February 7, 2019 – Certara has recently published four peer-reviewed MIPD papers; its progress is generating strong interest from industry, health care professionals and regulators.
PRINCETON, NJ – February 4, 2019 – Certara today announced that Justin Edge has joined Certara as President of Synchrogenix, the company’s regulatory science division.
January 29, 2019 – New features designed to support the delivery of safer, more effective medications include advanced food staggering and tumor models for optimizing trial design and dose selection.
Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2018 were supported by Certara software or services.