PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.
PRINCETON, NJ – Jan. 8, 2020 – Certara’s Simcyp® Simulator’s MechDermA™ model provided safety label claim and pediatric dosing information without the need for testing in clinical patients for a topical drug product.
PRINCETON, NJ – Dec. 10, 2019 – LEO Pharma has licensed Certara’s proprietary Simcyp®️ Population-based Simulator and joined its Consortium.
November 21, 2019 PK Submit generates PK CDISC domains automatically, allowing sponsors to file regulatory submissions faster, while also improving data organization and compliance
Certara Scientists to Present Their Latest Modeling and Simulation Advances at 2019 AAPS PharmSci 360
Certara will host two Phoenix WinNonlin™ Lunch and Learns and also lead 18 workshop, presentation and poster sessions on model-informed drug development
PRINCETON, NJ – Nov 1, 2019 – Certara thought leaders from its Evidence & Access division will present 12 posters at ISPOR Europe.
Oct 18, 2019 Sessions feature physiologically-based pharmacokinetic (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) and quantitative systems pharmacology (QSP) modeling and simulation
Oct 16, 2019 The most influential scientific research consortium of its kind: 37 biopharmaceutical companies work in a pre-competitive environment to advance PBPK modeling and simulation, progress new drug and biologics research, create new regulatory frontiers, foster ongoing modeling and simulation education, and present industry awards
Certara Launches BaseCase Data Studio, Enabling Pharma and MedTech Clients to Conduct Advanced Data Analyses During Value-based Product Discussions
Oct 1, 2019BaseCase platform can now perform live statistical modeling and sophisticated data analyses, delivering evidence-based claims to support value messages during payer, provider and HCP discussions
FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology