Inactive

The U.S. Food and Drug Administration, Rockville, MD intends to award a firm -fixed price contract to renew FDA's subscription to Certara's Simcyp software licenses and associated maintenance. FDA int... The U.S. Food and Drug Administration, Rockville, MD intends to award a firm -fixed price contract to renew FDA's subscription to Certara's Simcyp software licenses and associated maintenance. FDA intends to issue and award, to Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way Sheffield, UK S1 2BJ. FDA's Office of Clinical Pharmacology currently uses Simcyp to conduct Physiologically based pharmacokinetic (PBPK) modeling to review Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions from sponsors. Reviewers and Pharmacometricians use the data to review sponsor submissions (pharmaceutical companies, academic institutions, and individuals) and adhere to schedules with timelines that must be met per the various user fee acts governing such work (Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Missioncritical functions. If submissions are submitted to the FDA using Certara software they must also be reviewed using the Certara software, therefore no other PBPK modeling tool will meet OCP's needs. There are no set-aside restrictions for this procurement, and the anticipated Period of Performance is 9/21/2022 - 09/20/2023. Certara UK Limited offers a product with capabilities that are not available from any other vendor, and controls all propriety rights for this product: