Certara

Overview

Certara is a global leader in model-informed drug development (MIDD), combining proprietary biosimulation software, advanced analytics, and strategic consulting services to accelerate drug discovery and development. The company serves over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Core Capabilities

Discovery & Preclinical: Certara provides predictive design solutions for small molecules and biologics, including cheminformatics, biosimulation, target identification, and in silico studies. Services support therapeutic window assessment, nonclinical planning (CMC, toxicology, DMPK), biomarker strategies, and First-in-Human trial design with IND support.

Clinical Development: Integrated services span early and late clinical phases, including trial design optimization, pharmacokinetic/pharmacodynamic modeling, real-time data analysis, statistical programming, and protocol development. Advanced modeling justifies dosing decisions; AI-empowered meta-analysis informs outcome selection.

Regulatory & Market Access: Certara streamlines global regulatory submissions with standardized, compliant documentation and expert regulatory support. Market access services include pricing, reimbursement, and patient access strategies; real-world evidence analysis; and value communication to payers and stakeholders.

Scientific Expertise: Over 350 scientific consultants and industry experts, including discovery scientists, clinical pharmacologists, data scientists, and regulatory specialists—many with prior agency experience. Customers have received 90% or more of all novel FDA drug approvals from 2014–2025.

Strategic Positioning

Certara emphasizes an integrated ecosystem bridging discovery to preclinical, translation to clinic, and clinic to market. The company invests continuously in innovation—recent additions include biosimulation for discovery (2025), cheminformatics (2024), scalable AI and generative pre-trained transformers (2023), and quantitative systems pharmacology (QSP) capabilities.