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 (…)
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
Affirms continued regulatory and industry adoption of biosimulation and technology to bring new drugs to patients PRINCETON, N.J.—Feb. 25, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic … Continued