Certara
Biosimulation leader accelerating safer, faster drug development from discovery to market access.
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Global leader in biosimulation/MIDD with 90%+ FDA novel approvals supported
Key Differentiators
- Global leader in biosimulation/MIDD with 90%+ FDA novel approvals supported
- integrated software-services ecosystem across full drug lifecycle
- regulatory-qualified tools used by FDA/EMA in evaluations.
Overview
Certara provides biosimulation software, technology-driven services, and consulting to accelerate drug discovery, development, regulatory approval, and market access for biopharma companies. Using model-informed drug development (MIDD), pharmacometrics, PBPK/QSP modeling, and AI tools, they optimize dosing, trial design, and submissions across all phases. Their solutions have supported 90%+ of FDA novel drug approvals since 2014.
Services & Capabilities
- Biosimulation software (Simcyp PBPK, Phoenix PK/PD)
- pharmacometrics & QSP consulting
- regulatory writing & submissions
- clinical trial design & biostatistics
- market access & HEOR
- drug development strategy (preclinical to commercial)
- AI platforms (Certara.AI, D360).
Competitive Position
- Global leader in biosimulation/MIDD with 90%+ FDA novel approvals supported
- integrated software-services ecosystem across full drug lifecycle
- regulatory-qualified tools used by FDA/EMA in evaluations.
Recent Developments
2024: Completed acquisition of Chemaxon. 2025: Q3 revenue $104.6M (+10%). 2026: New CEO Jon Resnick (Jan 2026); FY2025 revenue $418.8M (+9%); FY2026 guidance flat to +4% revenue.
Client & Partner Ecosystem
Biohaven (Nurtec), Dizal (Sunvozertinib), Biogen, Arvinas, Prelude Therapeutics, Charles River, Veeva Certara website, LinkedIn, ; Biohaven Pharmaceuticals (Nurtec ODT)
Technology Platform
Simcyp, Phoenix, Certara.AI, D360, GlobalSubmit; Simcyp Simulator
Therapeutic Focus
broad/all (oncology, rare disease, cell & gene therapy, vaccines, biologics, pediatrics)
Target Customers
biopharmaceutical companies, academic institutions, regulatory agencies
Sources
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