In this case study, the sponsor’s closing of a manufacturing site required that one of its top-selling products be made at a different facility, triggering FDA to request they demonstrate BE on that product. FDA suggested the sponsor might be...
A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for Lifecycle Maintenance (LCM) of their INDs. It was important to the Sponsor team that they received better responsiveness and minimal disruption of activities during transition in the new partnership. Regulatory GlobalSubmit™ eCTD Software Certara was able...
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding in Value Communication’. This series of blog articles examines the key success factors in creating customer engagement tools that effectively communicate the clinical value and...
Explore Certara’s Simcyp success stories, showcasing PBPK modeling achievements that reduce R&D costs and expedite drug development.
Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton, N.J., August 5, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has signed a definitive agreement to acquire Pinnacle...
Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and pharmaceutical development present some particularities and challenges in comparison to...
Our PBPK modeling software is the most widely adopted platform for PBPK modeling in drug development. Find out more about our Simcyp® Platform here.
Browse our free, educational webinars— covering topics including clinical pharmacology, pharmacometrics, PBPK modeling and simulation, regulatory writing, real world evidence, and market access, all available on-demand.
Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating advanced melanoma. As in the best practice case of ibrutinib, we generally perform physiologically-based pharmacokinetic (PBPK) simulations with model verification based on CYP3A4 strong inhibitor...
Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October 2015 at monthly and 6-week dosing options. Although aripiprazole was not a new drug, Aristada was a new, long-acting injectable formulation to combat this challenging...
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