Certara (CERT) announced the launch of its Non-Animal Navigator solution designed to help biopharmaceutical companies lead the transition ignited by the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The company said, “The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence…Based on Certara’s extensive experience working with FDA, EMA, and other major health authorities, the Non-Animal Navigator is a flexible solution that ensures each client’s development program is compliant, agile, and future ready. It offers clients: Strategic Regulatory Advice – Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment. Integrated Preclinical Development Plan – Build an integrated, weight-of-evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input. Optimized AI Enabled Modeling Toolkit – Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator(R), and ready-to-use mAb Quantitative Systems Pharmacology models.”
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