Modeling Great Solutions

Executive Summary

Modeling Great Solutions (MGS) is a Tel Aviv-based consulting firm that provides FDA-level pharmacometrics and model-based drug development services to pharmaceutical and biotech companies. Founded in 2020 by a former FDA Pharmacometrics Reviewer, MGS leverages deep regulatory expertise to help clients de-risk programs, optimize clinical trial designs, and strengthen regulatory submissions across oncology, hematology, cardiovascular, and immunology therapeutics. With a lean team of 10–50 specialists, the firm has carved out a niche in quantitative drug development, offering strategic insights that bridge the gap between complex modeling and regulatory decision-making. In a competitive landscape, MGS differentiates itself through its founder's direct FDA experience and a focus on model-informed drug development (MIDD) approaches that can accelerate timelines and reduce costly late-stage failures. The company's platform-stage status reflects its scalable consulting model and growing pipeline of client engagements, though its success hinges on sustained demand for specialized modeling services amid evolving regulatory expectations.

Upcoming Catalysts (preview)

• Q4 2026Announcement of a Major Pharma Partnership or Consortium60% success
• Q2 2026Release of a Publicly Recognized Case Study or Publication in a High-Impact Journal70% success
• Q3 2026Hiring of Additional Key FDA/Regulatory Alumni to Expand Capacity50% success