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Certara
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      • Solutions

        Transform your drug development journey with Certara’s comprehensive solutions. From molecule to market, we seamlessly integrate science, technology, strategic and regulatory expertise to solve your unique challenges.

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      • Regulatory

        Navigate complex regulatory landscapes with tailored strategies and AI-driven tools.

      • Non-Animal Navigator™

        Navigate complex regulatory landscapes with tailored strategies and AI-driven tools.

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        Accelerate breakthroughs with biosimulation and modeling to refine candidates and improve go/no-go decisions.

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        Streamline IND submissions with predictive modeling and dosing optimization.

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        Achieve first-in-human success with advanced simulation and precision dosing.

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        Deliver robust regulatory-ready data while optimizing trial design and commercial planning.

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        Demonstrate value and optimize pricing for global patient access.

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        Strategic Leadership

        Unify insights to accelerate drug development and achieve development milestones. Partner with Certara to unlock your pipeline’s potential.

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  • Software
      • Our software

        Certara’s software solutions offer transformative approaches across all drug development phases, aligning with recognized industry standards. By integrating advanced modeling, analytics, and automation, they break down silos, streamline workflows, and drive regulatory success.

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      • Featured software:
      • Phoenix™

        PK, PD, and toxicokinetic analysis and modeling

      • Pinnacle 21

        Data standardization and validation

      • Quantitative Systems Pharmacology

        Integrate biological and pharmacological insights to optimize drug efficacy and safety predictions

      • GlobalSubmit™

        Publish, review and transmit eCTD submissions

      • BaseCase

        Tell your interactive, data-driven value story

      • Simcyp™

        Predict drug behavior in diverse populations using advanced PBPK modeling and simulation

      • D360™

        Scientific informatics to access, analyze and visualize molecule and bioactivity

      • SEND Explorer®

        Visualize nonclinical data for trends and outliers

      • CoAuthor™

        GenAI, templates and structured content for regulatory writing

      • Chemaxon

        Enhance scientific discovery with chemical and biological intelligence

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      • Our services

        Transform drug development with our tailored services. From predictive modeling to market access strategies, Certara’s integrated services enhance decision-making, streamline processes, and make your drug a safer bet.

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      • Modeling and Simulation

        Optimize drug development using predictive biosimulation and modeling to inform dosing, safety, and efficacy decisions.

      • Biometrics and Data Science

        Deliver submission-ready datasets and analyses with advanced programming, validation, and data standardization.

      • Drug Development Support

        Streamline development with tailored MIDD driven strategies through all phases of development to optimize execution and decision-making.

      • Regulatory and Medical Communications

        Ensure global compliance and impactful medical narratives with expert regulatory documentation and strategy.

      • Real World Evidence and Market Access

        Leverage real-world data to craft value propositions, engage payers, and secure market access.

      • Therapeutic Specialities

        Centers of Excellence that address complex therapeutic challenges with specialized expertise in oncology, pediatrics, rare diseases, and more.

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      • Customers

        Certara tailors solutions for biotech, pharma, and CROs, addressing unique challenges to drive success.

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      • Biotech

        Fuel your breakthrough pipeline. With tailored guidance and integrated services, Certara helps biotech companies transform one success into sustainable growth and attract critical investment.

      • Large Pharma

        Open up silos, prioritize effectively. Certara empowers large pharma to optimize decision-making, align priorities, and achieve delivery across global teams and complex pipelines.

      • CRO

        Maximize efficiency, align seamlessly. Certara’s cutting-edge solutions ensure CROs stay ahead, improve client alignment, and deliver results with unmatched speed and precision.

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        Transforming Partnerships

        Certara collaborates with leading biotech, pharma, and CRO partners to tackle complex challenges, deliver innovation, and shape the future of healthcare.

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  • Resources
      • Resources

        With over 1,000 articles spanning categories and solutions, Certara’s resources is a geek haven. It’s all here—built for scientists who dare to think different.

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      • Learning Center

        Access expert articles, videos, and tools for drug development innovation.

      • Interactive Demos and Tools

        Experience Certara’s Technology in Drug Development.

      • PK/PD and Biosimulation Training

        Upskill your team with immersive, hands-on modules across multiple domains.

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        Leverage our expert forums and resources to optimize Certara solutions.

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        Stay updated on industry trends, best practices, and scientific insights.

      • Events & Webinars

        Join global experts for live and on-demand knowledge-sharing sessions.

      • Case Studies

        Explore real-world examples of success powered by Certara expertise.

      • White Papers

        In depth coverage of selected biosimulation and data science topics

      • Resources by solution
        Regulatory Discovery Preclinical Early Clinical Late Clinical Market Access & Commercial View all resources
  • Company
      • Explore Certara

        With over 1,550+ employees in more than 30 countries, over 28% of which have PhDs, our vision is to transform drug development for good.

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      • Leadership and Board of Directors

        Meet the visionary team driving Certara’s innovation and growth.

      • Locations

        Explore Certara’s global network of offices, serving clients worldwide.

      • Investor Relations

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      • Partnerships

        Discover how collaborations amplify our impact across the drug development ecosystem.

      • Regulatory Adoption

        Learn about regulatory agencies worldwide leveraging Certara solutions.

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        Join a global leader transforming the future of drug development. Explore opportunities to innovate, grow, and make a difference in transforming lives.

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1419 results found

Impact of Low-dose Ritonavir on Danoprevir Pharmacokinetics: Results of Computer-based Simulations and a Clinical Drug-drug Interaction Study Blog Post

Danoprevir, a potent, selective inhibitor of the hepatitis C virus (HCV) NS3/4A protease, is metabolized by cytochrome P450 (CYP) 3A. Clinical studies in HCV patients have shown a potential need…

Sex Differences in the Clearance of CYP3A4 Substrates: Exploring Possible Reasons for the Substrate Dependency and Lack of Consensus Blog Post

Sex differences in the clearance of substrates of Cytochrome P4503A (CYP3A4) have been reported frequently although there has been no consensus on reasons for variation in observations amongst drugs which…

Pharmacokinetics, Lymph Node Uptake and Mechanistic PK Model of Near Infrared Dye Labeled Bevacizumab After IV and SC Administration in Mice Blog Post

Our objective was to determine the pharmacokinetics, bioavailability and lymph node uptake of the monoclonal antibodybevacizumab, labeled with the near-infrared (IR) dye 800CW, after intravenous (IV) and subcutaneous (SC) administration…

Prediction of Drug Clearance in a Smoking Population: Modeling the Impact of Variable Cigarette Consumption on the Induction of CYP1A2 Blog Post

The objective of this study was to derive estimates of CYP1A2 abundance as a function of daily cigarette consumption and use these values to predict the clearances of CYP1A2 substrates…

Noninvasive Real-time Fluorescence Imaging of the Lymphatic Uptake of BSA-IRDye 680 Conjugate Administered Subcutaneously in Mice Blog Post

The goal of our studies was to determine lymphatic uptake of bovine serum albumin (BSA) using real-time noninvasive fluorescence imaging. BSA labeled with near-infrared dye (IRDye) 680 was used as…

Modeling and Simulation of Edoxaban Exposure and Response Relationships in Patients with Atrial Fibrillation Blog Post

Edoxaban is a novel, orally available, highly specific direct inhibitor of factor Xa and is currently being developed for the treatment and prevention of venous thromboembolism and prevention of stroke…

Placebo Response Changes Depending on the Neuropathic Pain Syndrome: Results of a Systematic Review and Meta-analysis Blog Post

The purpose of this study was to compare placebo responses in neuropathic pain syndromes through systematic literature review and meta-analysis. We used randomized placebo-controlled trials assessing pain intensity or pain relief…

Screening of Chemicals for Human Bioaccumulative Potential with a Physiologically-based Toxicokinetic Model Blog Post

Human bioaccumulative potential is an important element in the risk assessment of chemicals. Due to the high number of synthetic chemicals, there exists the need to develop prioritisation strategies. The…

Use of a Multistaged Time-dependent Inhibition Assay to Assess the Impact of Intestinal Metabolism on Drug-drug Interaction Potential Blog Post

In early discovery, compounds are often eliminated because of their potential to undergo metabolic activation and/or cytochrome P450 time-dependent inactivation (TDI). The blockbuster drug raloxifene is an example of a…

Physiologically-based PharmacoKinetic (PBPK) Modeling Tools: How to Fit with Our Needs? Blog Post

In 2005, a survey compared a number of commercial PBPK software available at the time, mainly focusing on ‘ready to use’ modelling tools. Since then, these tools and software have…

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