Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel drugs in lieu of conducting clinical studies PRINCETON, N.J.— March 7, 2023 – Certara, Inc….
A new class of complex biologics has emerged in recent years. These are classified in a broad category of live biotherapeutic products, and regulatory guidances have been written across the…
PRINCETON, N.J. – March 1, 2023 – Certara, Inc. (Nasdaq: CERT), announced today that John Gallagher will succeed Andrew Schemick as Chief Financial Officer, effective April 1, 2023. Mr. Schemick…
Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be a time-consuming, error prone and complex task. Certara’s software PK Submit provides a compliant solution…
While the new EU-CTR will help to streamline clinical trials, which will benefit both patients and researchers, there are some challenges for Sponsors adjusting to this new regulation.
Historically, the FDA has required drug discovery and development programs to include animal testing. This requirement has ended with the 2022 passage of the FDA Modernization Act. This change has…
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