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Biosimulation software enables researchers to model and simulate complex biological systems, aiding in the prediction of drug behavior, optimization of treatment strategies, and reduction of costs and time associated with traditional experiments. Biosimulation solutions facilitate collaboration, data integration, and regulatory compliance, empowering scientists to make informed decisions, accelerate drug development, and improve patient outcomes. As the industry leader in biosimulation, or quantitative drug development, Certara offers platforms and software solutions to modernize and accelerate the process of bringing drugs to patients. Our tools are designed to make your work easier so that you can spend more time on the science and insights and less time on administrative tasks and error-checking.

Biosimulation Software

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Phoenix™ PK/PD Platform

Certara’s Phoenix™ platform is the most comprehensive and widely used software for pharmacokinetic, pharmacodynamic and toxicokinetic modeling and simulation. Phoenix provides all the tools scientists need in a single, interoperable platform that enables them to share preclinical and clinical knowledge effortlessly across the organization through secure and consistent workflows.

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Simcyp™ PBPK Simulator

The Simcyp Simulator is the leading physiologically based pharmacokinetics (PBPK) platform for determining first-in-human dosing, optimizing clinical study design, evaluating new drug formulations, setting the dose in untested populations, performing virtual bioequivalence analyses, and predicting drug interactions.
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Learn more about Simcyp Biopharmaceutics

Simcyp™ Biopharmaceutics

Simcyp Biopharmaceutics is a cutting-edge platform within the Simcyp family, specializing in human PBPK modeling for clinical pharmacology studies. It enables realistic simulation of drug absorption, supporting various administration routes. With features like ADAM and M-ADAM models, IVIVC, and the SIVA toolbox, it offers comprehensive solutions for drug development. This platform stands as a vital tool in predicting drug behavior throughout the development cycle.

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The industry standard for pharmacokinetic / pharmacodynamic (PK/PD) analysis

Certara’s Phoenix platform is the leading PK/PD modeling and simulation software used worldwide by 11,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA.

Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with built-in, easy-to-use graphical user interface and textual editor for advanced analysis. Phoenix 8.4 offers features that support compliance and efficiency, including:

  • Visual workflows
  • High-quality tables and figures
  • Fully-integrated WinNonlin Validation Suite for fast automated software validation
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The industry standard for pharmacokinetic / pharmacodynamic (PK/PD) analysis
Simcyp Mechanistic Software
Simcyp Mechanistic Software

Simcyp predicts outcomes with leading biosimulation:

  • Physiologically based Pharmacokinetics (PBPK)
  • Quantitative Systems Pharmacology (QSP)
  • Virtual Bioequivalence (VBE)
  • Quantitative System Toxicology & Safety (QSTS)

Certara is the leading provider of mechanistic modeling software and consulting services, predicting outcomes for the global biopharm industry. The groundbreaking Simcyp Simulator is relied upon by pharmaceutical and biotech companies, academia and regulatory agencies, including the US FDA. Simcyp is committed to using technology and innovation to deliver safe and effective medicines to patients.

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Since 2014, 90% of novel FDA drug approvals received by our customers

Our customers, who use our biosimulation software and tech-enabled services, have received 90% of novel drug and biologic approvals by the FDA for the past 8 consecutive years. As the global leader in biosimulation, we work with more than 1,650 biopharmaceutical companies, leading academic institutions, and regulatory agencies worldwide, including all of the top 35 global biopharmaceutical companies by R&D spend. While most approved novel drugs have used biosimulation in their development pathway, we don’t believe that biosimulation was used to the extent it should have to further accelerate and improve the drug development process. Additionally, our technology keeps getting better and better to expand use cases for biosimulation. We see a significant opportunity for continued future penetration by our products and services.