Certara

Certara provides predictive modeling, biosimulation software, and regulatory consulting services for pharmaceutical and biotech companies throughout the drug development lifecycle. The company serves clients from discovery through commercialization, offering solutions that span preclinical modeling, clinical trial design, regulatory submissions, and market access strategies.

With over 1,550 global team members across 30 countries—including more than 440 PhDs—Certara combines scientific expertise with software platforms for pharmacokinetic modeling, data standardization, and regulatory compliance. The company's platforms include Phoenix Cloud for workflow automation, Pinnacle 21 for regulatory submission validation, and D360 for discovery research. Certara's technology has supported over 100 novel drug approvals and 325 label claims approved in lieu of clinical trials.

The company reports that its customers have received 90% or more of all FDA novel drug approvals from 2014 through 2024. Certara has collaborated on more than 8,000 customer projects in the last decade across therapeutic areas including oncology, hematology, diabetes, and rare diseases. Recognition includes Fortune Best Workplaces in Biopharma 2025 and Great Place to Work certification.

Consider Certara when your drug development program requires advanced biosimulation modeling, regulatory strategy expertise, or the ability to reduce clinical trial requirements through in silico approaches. The company's integrated platform of software and consulting services works best for organizations managing complex development programs across multiple phases or seeking to optimize trial designs using pharmacometric modeling.

Expect a high-touch engagement model leveraging PhD-level scientific expertise combined with proprietary software platforms. The company's track record suggests particular strength in supporting regulatory submissions and developing modeling strategies that satisfy health authority requirements for novel therapies.

Certara operates exclusively within pharmaceutical and biotechnology drug development, providing specialized services for therapeutic product development from discovery through market access. The company's healthcare focus centers on helping drug developers navigate regulatory requirements, optimize clinical trial designs, and demonstrate product value to payers.

Their expertise spans oncology, hematology, metabolic diseases, rare diseases, and other therapeutic areas requiring sophisticated pharmacokinetic/pharmacodynamic modeling. The company's platforms support CDISC data standards compliance and regulatory submission requirements for FDA, EMA, and other global health authorities.

Ideal clients are pharmaceutical companies and biotech firms developing novel therapeutics that can benefit from biosimulation, pharmacometric modeling, or advanced regulatory strategies. Organizations with complex development programs spanning multiple indications, those pursuing pediatric extrapolation, or companies seeking to optimize dosing strategies through modeling rather than additional clinical trials will find Certara's capabilities well-matched to their needs.