Biosimulation Thirty recent drug approvals ClinGenuity Phoenix Roadshows

Biosimulation: Predicting Outcomes

Supports dose selection, clinical trial design,
drug-drug interaction and drug labeling

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Certara Scientific Consulting

Biosimulation services for more than
50 recent drug approvals, labels,
and submissions

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ClinGenuity Acquisition

Synchrogenix, Certara’s regulatory
and medical writing consultancy,
acquires ClinGenuity

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Phoenix Roadshows

One day free seminars
on best practices in PK/PD modeling

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Biosimulation Software and Consulting for Drug Development

Certara, the leading biosimulation company, provides technology-enabled solutions to the global biopharmaceutical industry. We have brought together the leaders in biosimulation and regulatory writing—Pharsight, Simcyp, Tripos, Synchrogenix, and ClinGenuity —to create an integrated solution to quantitatively inform drug development. 

At what dose is a drug safe, efficacious and medically differentiated? In what patient population? With what concomitant medications? We employ the largest team of PhD’s in the industry who are applying math to medicine to answer the most challenging drug development questions, with certainty and predictability. 

Sounds great, but does it work? In the past three years, we have directly supported 50 new drug approvals, labels and submissions. Global regulators are now making key regulatory decisions, sometimes solely, based on the outcomes of biosimulation. Working with 1,500 companies, 6,000 scientists and leading regulatory agencies, we have substantially reduced the risk, time and cost required to get a drug to market.  


  • Make data-driven decisions at all stages of drug development through a quantitative framework
  • Accelerate regulatory approval through integrated strategy, analytics and regulatory writing
  • Leverage all available data on the drug in development, as well as public data on competitors, to achieve the target product profile.
  • Design safer, targeted and more efficient trials
  • Select the right dose for the right patients, the first time
  • Simulate virtual patients in hard to recruit or test patient populations, such as pediatric, elderly and/or organ impaired

Strengthening decision-making, increasing predictability and reducing safety risk by using our expert scientific modeling and regulatory writing professionals.

Our global scientific team applies quantitative analysis and predictive models of diseases, drugs and clinical trials to support strategic decisions and new drug submissions. Our scientists combine specialized clinical and regulatory knowledge and decision-support tools to optimize patient populations and doses and regimens, design optimal trials, evaluate safety risk, extrapolate virtual human data, and create clinical study reports and filing documents to expedite the drug development process. Learn More

Supporting model based, cross-disciplinary, and translational approaches to drug discovery and development.

Solutions for modeling, simulation, and analysis, as well as scientific informatics throughout the discovery and development process. Anchored by the unique Simcyp population-based simulator and Phoenix&o® WinNonlin®, the ‘gold’ standard for PK/PD and non-compartmental analysis, our technology suite is unmatched in the industry. Virtually all the leading pharmaceutical companies and regulators, including the FDA, use our technology to affirm IND and NDA claims and to consider the substitution of biosimulation for clinical studies. Learn More