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Author: Certara

Certara Launches New Synchrogenix™ Writer Software to Accelerate the Regulatory Submission Process

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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

Certara Strengthens Model-Informed Drug Development Team with Four Executive Hires

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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

Demonstrating Virtual Bioequivalence (VBE) using the Simcyp Simulator™

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Demonstrating bioequivalence (BE) remains the key regulatory hurdle for genericdrug approval. As a result, some branded drugs remain on the market well pastthe originator’s patent expiration, without cost-effective generic alternatives thatcould benefit patients. Model-informed drug development (MIDD), specificallyphysiologically-based pharmacokinetics (PBPK) leveraging in vitro data, is a proven,cost-effective option to consider in lieu of running an … Continued

Strategic Evidence & Value Communication Symposium

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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.

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

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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

Empowered Patient Podcast: Using Biosimulation to Develop Pediatric Therapeutics with Lynne Georgopoulos Certara

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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

Scientific Computing World: Connecting Science

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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 (…)

Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe

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Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— March 2, 2021– Certara, Inc., a global leader in biosimulation, today announced the acquisition of AUTHOR!, a company that provides medical writing and statistical analysis of clinical trial data to global pharmaceutical and biotechnology companies.  Founded in 1998, AUTHOR! is based near Amsterdam … Continued

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