The Food and Drug Administration awarded a definitive contract to Simulations Plus Inc. for quantitative in vitro in vivo extrapolation framework development on September 30, 2026, with a firm fixed price ceiling of $1,650,102 and ultimate completion date of December 29, 2029.
The originating solicitation is the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which seeks research and development proposals to advance regulatory science and innovation. The overarching objective is to establish a quantitative in vitro in vivo extrapolation framework capable of predicting the influence of formulation composition, digestion behavior, chylomicron binding, and prandial state on drug bioavailability. Place of performance is Takoma Park, MD. The procurement carried no set-aside. The underlying BAA, posted November 21, 2025, with amendments through January 16, 2026, operates under FAR 6.102(d)(2) and 35.016 and invites extramural research from eligible organizations including private sector organizations, FFRDCs, and academic institutions, with multiple awards anticipated and cost-reimbursement contract types preferred by the government.