Complementary technologies accelerate and help assure success in the drug development process Princeton, N.J., October 4, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness. … Continued
Cloud-based and validated regulatory software automates and advances quality of patient narratives Princeton, N.J., September 30, 2021 – Certara, a global leader in biosimulation, today announced the launch of Synchrogenix™ Writer, a new regulatory SaaS product that expedites the authoring and review of patient narratives. Patient narratives describe adverse events or adverse drug reactions and … Continued
New executives bring cross-disciplinary expertise and diversity to the company’s premier global Integrated Drug Development team PRINCETON, N.J.—May 17, 2021. Certara, Inc, (Nasdaq: CERT), the global leader in biosimulation, announced the appointments of four executives to its growing model-informed drug development team: Dr. Matt Zierhut as Vice President, Model-Based Meta-Analysis, Dr. James Dunyak as Senior … Continued
Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various … Continued
Lynne Georgopoulos, VP Regulatory Strategy, Certara describes the company’s platform to optimize pediatric drug development using biosimulation. With an eye on pediatric diseases, Certara is employing modeling and simulation to determine how a drug developed for adults may be metabolized in children, including neonates. They are also operationalizing clinical trials to be more efficient and … Continued
Interconnection is an imperative for the modern laboratory, and seamless integration is mandatory from the perspective of the end user, who is generally a scientist. That’s the view of Leif Pedersen, president of software at Certara (…)