Simulations Plus Inc.

Simulations Plus Inc., headquartered in Durham, North Carolina, develops physiologically-based pharmacokinetic (PBPK) and mechanistic absorption modeling software for pharmaceutical research and regulatory assessment, selling to federal agencies on a full-and-open basis as a prime contractor (94% of recent awards) with specialized software licenses and research grants.

Simulations Plus is a for-profit manufacturer of computational modeling goods and software, with two named subsidiaries: Dilisym Services, Inc. (a self-certified small disadvantaged business) and Words Plus Inc. The vendor competes without SBA set-aside designations across all recent prime awards. Core products include GastroPlus (a PBPK simulation platform modeling drug absorption, pharmacokinetics, and pharmacodynamics across multiple administration routes), ADMET Predictor (an artificial intelligence and machine learning computational platform for drug property prediction and regulatory assessment), and DDDPlus (a population-based bioavailability and bioequivalence modeling platform). The vendor's capability portfolio centers on virtual bioequivalence studies, in vitro-in vivo extrapolation frameworks, and predictive modeling for drug formulation effects on bioavailability.

The Food and Drug Administration dominates customer concentration, accounting for 20 awards and $3.3 million in combined potential value — roughly 73% of all recent potential value. A September 2026 definitive contract from FDA carries $1.65 million to establish a quantitative in vitro in vivo extrapolation framework predicting formulation composition effects on drug bioavailability through December 2029 under the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science. Secondary customers include the Army Materiel Command Research Development and Engineering Command ($362 thousand across five awards), the Centers for Disease Control and Prevention Pittsburgh ($251 thousand across seven awards), the Army Medical Command ($209 thousand across five awards), and the Defense Health Agency ($144 thousand). The vendor also holds federal grant awards as a primary recipient from the National Institute of General Medical Sciences, the National Center for Advancing Translational Sciences, and the Center for Drug Evaluation and Research, performing research on drug discovery similarity scoring, amorphous solid dispersion bioequivalence modeling, and biologics-induced liver injury prediction.

Most recent awards cluster in September 2026: an FDA purchase order for $343,999 for GastroPlus and DDDPlus PBPK platform software licenses (completion August 2030), an FDA purchase order for $68,213 for ADMET Predictor software for the Office of Cosmetics and Colors (completion August 2031), and a CDC purchase order for $113,357 for simulation software licenses (completion March 2031). Recompete exposure in the next twenty-four months totals two awards with combined potential value of $56 thousand. Award volume has fluctuated (eight awards in 2021, two in 2022, one in 2023, five in 2024, and five through September 2026); the source shows combined potential value of $4.5 million against obligated dollars of $10.5 million, indicating mature contracts with drawdown activity exceeding stated ceilings.

The vendor operates as a sub contractor on two named federal contracts: a University of Florida sub-award (dating to March 2024) for GastroPlus model enhancement and COPD/asthma physiopathology implementation, and a University of Connecticut sub-award (February 2022) for in vitro-in vivo correlation method enhancement and physiologically-based pharmacokinetic modeling for long-acting injectable suspensions. Simulations Plus also holds federal grant sub-awards from University of Connecticut (PBPK model-based mechanistic in vitro-in vivo correlations for long-acting injectables, February 2026) and Northeastern University (oral modified-release tablet evaluation, September 2024). Service Contract Inventory data shows minimal SCI-reportable service-contract presence — five records as named subcontractor across FY2022–FY2025, ranging from 0.2 to 0.6 FTEs — reflecting the vendor's primary business model of software licensing and research grants rather than labor-intensive federal services. The vendor's federal footprint is predominantly software goods (44 awards under NAICS 511210, Software Publishers) and software intellectual property licensing rather than services delivery, with award concentration in FDA regulatory science and Defense health research missions.