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Best Practices in Clinical Pharmacology Gap Analysis

Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.

FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.

D360 Partner

D360 Partner is an affordable add-on product for D360 for external partners that allows for seamless, secure sharing of data and analysis while advancing communication and collaboration.

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