In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology...
This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple...
Increase the efficiency of regulatory and medical writing with Certara’s purpose-built Generative AI-Enabled Writing Software.
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....
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...
© 2025 Certara. All Rights Reserved. | Privacy policy
