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…
Active Definitive Contract Awarded Last action
- Contract number
- 75F40126C00063
- Awardee
-
Simulations Plus Inc. UEI MZN6WDBMXN24
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $575,554
Award facts
- Opportunity
-
- FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Special Notice · FDABAA2600123 · Posted Nov 21, 2025
- Contract value 35% obligated
-
- $651,399.00 Current, with exercised options
- $1,650,102.00 Potential, with all options
- Completion date 2% complete
-
- Current, with exercised options
- Potential, with all options
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 257 offers Basic Research
- Pricing
- Firm Fixed Price
- Place of performance
- Takoma Park, MD 20901, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
About this award
The Food and Drug Administration awarded a definitive contract to Simulations Plus Inc. for $1.65 million on September 30, 2026, 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.
The contract is firm fixed price with no set-aside. Place of performance is Takoma Park, MD 20901. The ultimate completion date is December 29, 2029.
The award derives from the FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, posted November 21, 2025. The BAA solicits basic and applied research and development proposals to support regulatory science and innovation across FDA-regulated domains, with research priority areas including new approach methodologies, analytical and computational methods, biomarkers, and clinical outcome assessments. The opportunity is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services). Simulations Plus develops physiologically-based pharmacokinetic and mechanistic absorption modeling software for pharmaceutical research and regulatory assessment, with core products including GastroPlus, ADMET Predictor, and related simulation modules.
Description
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 and
Quick answers
Who was awarded contract 75F40126C00063?
75F40126C00063 was awarded to Simulations Plus Inc. by Food and Drug Administration (Department of Health and Human Services) on September 30, 2026.
How much is contract 75F40126C00063 worth?
The government has obligated $575,554 on 75F40126C00063. Its current value, with exercised options, is $651,399. Its potential value, with all options, is $1,650,102.
Was contract 75F40126C00063 competed?
The extent of competition for 75F40126C00063 was full and open competition. The government received 257 offers.
On GovTribe
See this award's full record
- Every transaction and funding action
- The awardee's other awards and teaming partners
- Similar awards and recompete opportunities
- Ask GovTribe AI about this award