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Increase the efficiency of regulatory and medical writing with Certara’s purpose-built Generative AI-Enabled Writing Software.
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market. The company leveraged FDA’s accelerated approval program; it was one of the first to be awarded breakthrough status by the agency....
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study
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...
Takeover of lifecycle maintenance of investigational new drug applications Case Study
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...
Succeeding in Value Communication: Introduction Blog Post
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...
Simcyp Success Stories Page
Explore Certara’s Simcyp success stories, showcasing PBPK modeling achievements that reduce R&D costs and expedite drug development.
Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data Press Release
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...
What does the Clinical Pharmacology Plan for a Biologic Look Like? On-Demand Webinar
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...
Simcyp Page
Our PBPK modeling software is the most widely adopted platform for PBPK modeling in drug development. Find out more about our Simcyp® Platform here.
On Demand Webinars Page
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.
