There are numerous instances where clinical data may be unavailable or sparse. However, this should not hinder the progress of your project. Certara’s modeling and simulation services provide valuable insights, de-risk your projects, optimize decisions, and accelerate timelines across all phases of drug development. Our technology-backed services leverage our proprietary platforms for model-informed drug development (MIDD) and are trusted by regulatory authorities worldwide.
Modeling and Simulation Services
Transform drug development with the power to predict
Confident decision-making starts with biosimulation
120
novel drugs approved by regulators using the Simcyp Simulator
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making
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Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
Our experienced pharmacometrics services team helps quantify drug-patient interactions, optimize development & regulatory choices.
Global consulting team applying PBPK modeling to all stages in drug development.
Choose Certara's Quantitative Systems Pharmacology (QSP) consulting services to enhance drug development with computational modeling and experimental data.
Leverage Certara’s expertise in model-based meta-analysis to enhance trial design and decision-making.
Engage our expert QSTS scientific consultants to identify drug toxicity earlier and decrease time to bring your drugs to market.
Virtual Bioequivalence (VBE) is when bioequivalence of generic is demonstrated using modeling and simulation in lieu of clinical studies
Streamline first-in-human studies with physiologically based modeling to optimize dosing and reduce trial risks.
Analysis and strategies with the main objective of ensuring a successful drug development program.
Certara’s team of pharmacometrics consultants, PBPK programmers, regulatory writers, and submission experts can support your regulatory submissions.
Model-informed solutions drive results
Beyond providing essential information, Model Informed Drug Development (MIDD) builds bridges between development phases by creating opportunities to share insights.
Tailored insights
Customizable solutions prioritize key opportunities, optimizing design and minimizing risk.
Proven success
Engage with a partner trusted by the world’s leading pharmaceutical innovators.
Connect insights
Our solutions drive fluid information exchange, enhancing your ability to make decisions across all drug development stages.
Modeling and simulation resources
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Let’s collaborate to transform your drug development. Reach out today to discover faster and safer predictive solutions with Certara by your side.
Tailored strategies for your unique challenges.
Trusted by global regulatory agencies.
Proven success in driving efficiencies and results.
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Discover more about biosimulation
Early Development: De-risking Drug Development with PBPK and CMC
Blog: “Key Strategies for Early Success”
Explore how integrating Chemistry, Manufacturing, and Controls (CMC) with physiologically based pharmacokinetic (PBPK) modeling reduces risks in early drug development, streamlines processes, and provides robust data for better decision-making.
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Early Clinical: Adaptive Trial Design for Phase 1
Webinar: “Optimizing Phase 1 Dose Finding”
Learn how adaptive trial design accelerates Phase 1 dose-finding studies, improves decision-making, and enhances safety and efficacy evaluations for early-stage drug candidates.
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Late Clinical: Waiving Clinical Studies with Modeling
eBook: “Accelerating Development for Kinase Inhibitors”
Discover how modeling and simulation enable clinical study waivers for kinase inhibitor drugs, expediting development timelines, reducing costs, and providing robust evidence for regulatory approval.
Learn more