Simulations Plus

Simulations Plus is a biosimulation software and consulting company with over 30 years of experience supporting scientists and drug development teams across the full drug lifecycle — from discovery through commercialization. The company bridges artificial intelligence and machine learning, physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), quantitative systems toxicology (QST), and pharmacometrics into integrated, science-based solutions that increase confidence in model-informed drug development (MIDD).

Simulations Plus serves pharmaceutical and biotechnology scientists who require trusted software and expert guidance for ADMET prediction, biopharmaceutics, PK/PD analysis, and mechanistic modeling. The company offers both innovative software platforms and hands-on consulting services, enabling teams to move from early discovery to regulatory submission with greater speed and confidence through mechanistic models and AI-enabled workflows.

Core Software Products

• GastroPlus® — A mechanistically based simulation software package for PBBM/PBPK modeling that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal, subcutaneous, and intramuscular absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals. Modules include ADMET Predictor® integration, AssessmentsPlus™, Biologics, Drug Drug Interaction™, GastroPlusGPT™, IVIVCPlus™, Metabolism & Transporter, Optimization, Orchestrator, PBPKPlus™, PDPlus™, PKPlus™, and P-PSD.
• MonolixSuite™ — A fast, easy-to-use, and powerful suite of applications built for model-informed drug development computing, focused on pharmacometrics analysis, modeling, and simulation. The suite includes Monolix®, PKanalix®, and Simulx®.
• ADMET Predictor® — The flagship machine learning platform for ADMET modeling, featuring extended capabilities for data analysis, metabolism prediction, and AI-driven drug design. Modules include AI-Driven Drug Design (AIDD), ADMET Modeler™, DILIsym® Inputs Module, High-Throughput Pharmacokinetic (HTPK) Simulation, MedChem Studio™, Metabolism, Physicochemical and Biopharmaceutical (PCB), Toxicity, and Transporters.
• DILIsym® — Quantitative Systems Toxicology (QST) software designed for use during drug development to assess the potential drug-induced liver injury (DILI) hazard of individual molecules and to provide mechanistic insight into observed DILI responses. Key modules include PBPK, Mitochondrial Function, Bile Acids, Reactive Nitrogen/Oxygen Species, Innate Immunity, Hepatocyte Life Cycle, Clinical Readouts, and SimPops®.
• Thales — An end-to-end quantitative systems pharmacology (QSP) platform for building models, optimizing simulated populations to clinical data, and visualizing and analyzing simulation results.
• Pro-ficiency — A next-generation Performance Management and learning engine platform that houses complex content for training purposes, offering lifelike simulation, detailed data tracking, and advanced analytics — going beyond traditional learning management systems.

Consulting Services and Solutions

• Experienced scientific consultants support programs at every stage of the drug development lifecycle, including Discovery, Development, Clinical Operations, and Commercialization.
• Specialized consulting packages are available, including Consult + Coach, First-in-Human Simulator, NAMVantage™, and a Pulmonary Package.
• A Concierge service and a dedicated Regulatory Strategies Center of Excellence are offered to provide targeted strategic support.
• Learning Services are available to help teams build internal modeling and simulation capabilities.

Education, Events, and Resources

• Simulations Plus hosts a broad range of educational and scientific events, including webinars, live workshops, on-demand workshops, and scientific meetings.
• Example offerings include courses on Bioequivalence and Applied Pharmacometric Principles, as well as webinars on combining machine learning and high-throughput PBPK to accelerate early drug development.
• A comprehensive Resource Center provides access to blog posts, journal articles, flyers, posters, presentations, press releases, videos, and white papers.

With three decades of expertise and a continuously expanding portfolio of software and scientific services, Simulations Plus remains a trusted partner for life sciences organizations seeking to apply modeling, simulation, and AI-driven approaches across the entire drug development continuum.