Simulations Plus, Inc.

Simulations Plus, Inc. is a leading provider of modeling and simulation software and consulting services primarily for the biopharmaceutical industry. The company's mission is to create value for its customers by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. Headquartered in Research Triangle Park, North Carolina, U.S., Simulations Plus has been committed to improving quality of life through its solutions for over 30 years. [3, 5, 6, 9, 12, 13]

The company operates through two main segments: software and services. Its comprehensive offerings include biosimulation software and solutions that bridge artificial intelligence (AI) and machine learning (ML), physiologically based pharmacokinetics (PBPK), quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Key software products in its portfolio include GastroPlus®, MonolixSuite™, ADMET Predictor®, DILIsym®, and Thales™. These advanced technologies are licensed and utilized globally by major pharmaceutical, biotechnology, chemical, and consumer goods companies, as well as regulatory agencies worldwide. [2, 4, 6, 11, 13, 14]

Simulations Plus is recognized as a global leader in model-informed and AI-accelerated drug development. Recent strategic initiatives include collaborations with large pharmaceutical companies to advance AI workflows across the drug development lifecycle, integrating AI within scientifically grounded modeling frameworks. The company has also undergone leadership changes and a restructuring plan in 2025, with Shawn O'Connor serving as Chief Executive Officer. Simulations Plus continues to report financial results and engage in partnerships to advance predictive frameworks and the responsible deployment of AI in drug development. [5, 8, 10, 11, 14]