Certara Quantitative Systems Pharmacology (QSP) modeling software is a leading-edge platform designed to transform biopharmaceutical R&D by integrating computational modeling with experimental data. By leveraging this advanced solution, drug developers can predict efficacy and safety outcomes, explore therapeutic strategies, and make informed decisions throughout the drug development lifecycle. Our regulatory-ready QSP software provides reproducible models that are trusted by global regulators, including the FDA, EMA, and PMDA.
Quantitative Systems Pharmacology
Regulatory-ready systems modeling software to optimize drug development
Learn more about our Quantitative Systems Pharmacology modeling software
Regulatory-Ready Platform: Provides reproducible and reliable models for confident decision-making.
Virtual Trials with Virtual Patients: Enables simulation of diverse patient populations to optimize clinical trial designs.
Innovative Disease Modeling: Supports disease-specific platforms for immunogenicity, immuno-oncology, and neurodegenerative diseases.
Accelerate drug development with advanced mechanistic modeling
Certara’s QSP Software is designed to address the most complex challenges in drug discovery and development. By combining big data with quantitative systems pharmacology, the platform enables dynamic modeling of biological pathways, drug interactions, and disease processes. This comprehensive approach empowers researchers to predict clinical outcomes, optimize dosing regimens, and accelerate time-to-market for innovative therapies.
Predictive insights for efficacy and safety
Simulate drug effects across diverse populations, accounting for genetic, biological, and pharmacological variability.
Streamlined decision-making
Leverage evidence-based models to prioritize compounds and determine go/no-go milestones.
Integration with PBPK models
Combine QSP and PBPK modeling for a robust understanding of drug behavior and response.
Regulatory-ready modeling for global compliance
Certara’s QSP Software meets the rigorous standards of global regulatory agencies, ensuring reproducibility and reliability in model-based submissions.
AssessTM
- Assess early feasibility using this point-and-click software to assess safety, efficacy, and therapeutic index
- Simulations of pre-built and bespoke models across a variety of therapeutic modalities and disease areas
- Inform target selection, project clinical dose requirements, design, and identify risks in your programs
QSP Designer
- Graphical UI QSP software that facilitates creation and editing of a biological process for a given compound
- Key QSP functionalities integrated in one single environment
- Ongoing “learn and confirm” cycles ensure consistently updated and calibrated models
QSP platform models for multiple areas
Certara offers Quantitative Systems Pharmacology (QSP) platform models across diverse therapeutic areas, enabling data-driven insights to accelerate drug development. Our tailored solutions integrate complex biological systems to support informed decision-making in research and clinical settings.
AssessTM model packs
Assess™ offers several libraries of monospecific and bispecific, single-compartment and multicompartment models covering common pharmacologies.
Related resources
Early Feasibility Assessment
Early Feasibility Assessment (EFA), a quantitative approach to early discovery, to help predict whether a therapeutic has a reasonable chance of success.
Watch on-demand
Hallmarks of Neurodegenerative Disease: A Systems Pharmacology Perspective
Explore the critical challenges and innovations in modeling neurodegenerative diseases.
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Dose Optimization using the Gene Therapy Virtual Twin Platform
A novel and proven approach for real-time, iterative and personalized dosing.
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QSP Services
Leverage the knowledge of the world’s largest global QSP team to tackle your drug development challenges.
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Meet the QSP software experts
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Experts
Josh Apgar
VP, QSP Software and Products
Biophysics and bioengineering expert with 20+ years' experience leading teams to innovate scalable QSP software solutions.
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Experts
Andrzej Kierzek
VP, QSP R&D
Driving innovation in QSP with 25+ years of expertise in computational systems biology, leading a team of 20+ scientists to build cutting-edge models and knowledgebases
ConnectRequest a demo and more information
Discover how Certara’s QSP Software can accelerate your drug development program. With advanced modeling tools and expert consultation, our platform empowers you to overcome challenges and deliver innovative therapies faster.
Gain insights into predictive modeling for efficacy and safety.
See how pre-built model packs are used to quick-start your analyses.
Explore disease-specific platforms for immunogenicity, oncology, and neurodegenerative diseases.
Learn how to optimize clinical trial designs with virtual patient populations.
Why choose Certara’s QSP software?
Certara has redefined the landscape of quantitative systems pharmacology by building robust, regulatory-ready platforms that combine innovation with scientific rigor. Trusted by global regulatory authorities, our QSP solutions empower researchers to tackle the complexities of drug development with confidence and precision.
Our team of world-renowned experts, including leaders in systems pharmacology and computational biology, ensures that our software is at the forefront of innovation. By partnering with Certara, you gain access to decades of expertise and a suite of tools designed to optimize your entire drug development pipeline.