Certara
VerifiedBiosimulation and regulatory software spanning discovery to market access
- Deployment Cloud Based, On Premise
- Starting price Quoted on request
- Free trial Not offered
- Best for Medium Business, Large Enterprise
What is Certara?
Certara sells drug development software organised by development phase rather than by technical function, which makes it unusually easy to place against a pipeline. Its solutions run from discovery through preclinical, early clinical and late clinical to market access and commercial, with regulatory strategy running alongside. The vendor combines science, technology, and strategic and regulatory expertise, so software is sold with consulting rather than as a standalone licence.
Model-Informed Drug Development is the intellectual core. The argument is that predictive modelling reduces development risk and accelerates decisions, so candidates are refined and go or no-go calls made earlier, when they cost less. Simcyp applies physiologically based pharmacokinetic modelling to predict drug behaviour across diverse populations, which matters for dosing in groups rarely represented in trials. Phoenix handles pharmacokinetic, pharmacodynamic and toxicokinetic analysis and modelling. Early clinical work uses simulation for first-in-human success and precision dosing, and preclinical work uses predictive modelling and dosing optimisation to streamline IND submissions.
The regulatory and data tools address the submission itself. Pinnacle 21 covers data standardisation and validation against recognised standards, GlobalSubmit publishes, reviews and transmits eCTD submissions to health authorities, and CoAuthor applies generative AI, templates and structured content to regulatory writing. SEND Explorer visualises nonclinical data for trends and outliers. On the science side, D360 provides scientific informatics for accessing and visualising molecule and bioactivity data, Chemaxon supplies chemical and biological intelligence, and Certara IQ integrates biological and pharmacological insight to optimise efficacy and safety predictions. BaseCase builds interactive value stories for market access, and Certara.AI is the AI platform across the portfolio. A Non-Animal Navigator addresses the shift away from animal testing. Pricing is not published.
Key Features of Certara
- Simcyp physiologically based pharmacokinetic modelling and simulation
- Phoenix for PK, PD and toxicokinetic analysis
- Model-informed drug development strategies
- Pinnacle 21 data standardisation and validation
- GlobalSubmit eCTD publishing and transmission
- CoAuthor generative AI for regulatory writing
- SEND Explorer for nonclinical data visualisation
- D360 scientific informatics for molecule and bioactivity data
- Chemaxon chemical and biological intelligence
- Certara IQ for efficacy and safety prediction
- BaseCase interactive value stories for market access
- Certara.AI platform built for life sciences
- Non-Animal Navigator for non-animal testing strategies
- Precision dosing support for first-in-human studies
- Regulatory strategy consulting alongside the software
Certara Pricing
Quoted
Quoted on request
No pricing is published. Cost depends on which products are licensed and the level of consulting included.
Certara Specifications
- Cloud Based
- On Premise
- Web App
- Windows
- Medium Business
- Large Enterprise
- Phone
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