Simulations Plus Inc.

Simulations Plus Inc., headquartered in Durham, North Carolina, develops and licenses physiologically-based pharmacokinetic (PBPK) and mechanistic absorption modeling software for federal pharmaceutical research, regulatory assessment, and drug development; the company operates as a prime contractor on small-dollar software license purchase orders and cooperative grant agreements with health agencies, and as a subcontractor on university-led research projects, competing in full-and-open procurements without set-aside designations.

Simulations Plus is a for-profit manufacturer of goods with two named subsidiaries: Dilisym Services, Inc. (self-certified Small Disadvantaged Business) and Words Plus Inc. The company's core product portfolio centers on GastroPlus, ADMET Predictor, DDDPlus, MembraneePlus, and related simulation software modules that model drug absorption, pharmacokinetics, pharmacodynamics, and bioequivalence across multiple administration routes and formulation types. Representative prime contract work includes a $375,965 firm-fixed-price purchase order from the Food and Drug Administration (awarded August 2021) for GastroPlus, DDDPlus, and MembraneePlus software licenses; a $144,335 Defense Health Agency purchase order (September 2022) for GastroPlus licenses supporting analysis research with ultimate completion in September 2025; a $113,357 Centers for Disease Control and Prevention purchase order (June 2026) for simulation software licenses running through March 2031; and a $55,764 Environmental Protection Agency Office of Research and Development option year exercise (May 2024) for ADMET Predictor and GastroPlus software, representing the specialized proprietary software the EPA sources as sole-source procurements.

Customer concentration tracks to the Department of Health and Human Services and defense medical research. The Food and Drug Administration accounts for 17 awards with $1.3 million combined potential value, dominating both award count and dollars and capturing nearly 52 percent of the portfolio's combined potential value. The Centers for Disease Control and Prevention, National Institutes of Health National Cancer Institute, and Environmental Protection Agency Office of Research and Development round out the top tier by award count, while the Army Materiel Command Research Development and Engineering Command and Army Medical Command surface in the top five by potential value ($362 thousand and $209 thousand, respectively). Across the top five customer agencies, 68 percent of awards are represented.

Simulations Plus acts as a prime recipient on five federal grant awards from biomedical research sponsors. Recent grant work includes a September 2024 project grant from the National Institute of General Medical Sciences on improving similarity scoring in drug discovery through water-molecule considerations in ligand shape matching; a September 2024 cooperative agreement with the FDA's Center for Drug Evaluation and Research on in vitro mechanistic understanding of amorphous solid dispersion drug products in simulated gastrointestinal conditions (ultimate completion August 2027); a September 2023 cooperative agreement with CDER on development and validation of a workflow for virtual bioequivalence studies using PBPK models (ultimate completion August 2026); an August 2021 cooperative agreement with CDER on dermal drug product quality and bioequivalence assessment through advanced mechanistic absorption modeling and PBPK simulation (completed August 2024); and a November 2021 project grant from the National Center for Advancing Translational Sciences on software for predicting biologics-induced liver injury (completed February 2022). The company subcontracts on university-led research as well: Simulations Plus serves as a sub-recipient to the University of Connecticut on a February 2026 grant sub-award addressing PBPK model-based mechanistic in vitro–in vivo correlations for long-acting injectable suspensions, and to Northeastern University on a September 2024 grant sub-award evaluating oral modified-release tablets. Under a University of Florida prime subcontract (March 2024), Simulations Plus provides modeling work and enhancement of the PCAT physiologically-based absorption model in GastroPlus software, including implementation of COPD and asthma physiological pathologies. The company also subcontracts with the University of Connecticut on a contract research project (February 2022) on enhancement and validation of in vitro–in vivo correlation methods for long-acting injectable drug products.

Award activity has been sparse and volatile: eight awards in 2021, two in 2022, one in 2023, five in 2024, and two in 2026 year-to-date, with four awards (combined potential value $432 thousand) reaching ultimate completion inside the next twenty-four months. Service Contract Inventory data covering federal service contracts above the $150,000 threshold shows minimal SCI-reportable activity — three records across fiscal years 2022 through 2024, all as named subcontractor engagements, with 0.2 FTEs in FY2022 and 0.5 FTEs in FY2024 — reflecting that Simulations Plus revenue primarily flows through software license sales (purchase orders and grants) rather than billable labor on service contracts. The combined potential value across all 66 awards (62 prime, four sub) stands at $2.5 million, though the combined dollars obligated across the portfolio reaches $9.8 million, indicating that prior year awards are being exercised and renewed at rates exceeding their initial ceiling values. Simulations Plus operates as a 94 percent prime by award count, indicating it holds its own customer relationships and licensing agreements rather than feeding primarily through other primes as a subcontractor.