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Certara
  • Solutions
      • 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.

      • Discovery

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

      • Preclinical

        Streamline IND submissions with predictive modeling and dosing optimization.

      • Early Clinical

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

      • Late Clinical

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

      • Market Access & Commercial

        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

      • Software by solution
        Regulatory Discovery Preclinical Early Clinical Late Clinical Market Access & Commercial View software
  • Services
      • 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.

      • Services by solution
        Regulatory Discovery Preclinical Early Clinical Late Clinical Market Access & Commercial View services
  • Customers
      • 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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      • Featured resources:
      • 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.

      • Support

        Leverage our expert forums and resources to optimize Certara solutions.

      • Blog

        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.

        Learn more about us
      • 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

        Access financial reports, investor updates, and shareholder resources.

      • Partnerships

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

      • Regulatory Adoption

        Learn about regulatory agencies worldwide leveraging Certara solutions.

      • Responsibility

        See how Certara prioritizes sustainability, diversity, and community impact.

      • News

        Stay informed with the latest press coverage, press releases, and announcements.

      • Trust Center

        Understand our commitment to data privacy, compliance, and security.

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        Careers at Certara

        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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  • Solutions
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    • Quantitative Systems Pharmacology
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  • Solutions
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    • Regulatory
    • Non-Animal Navigator™
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  • Software
    • Software overview
    • Phoenix™
    • Pinnacle 21
    • Quantitative Systems Pharmacology
    • GlobalSubmit™
    • BaseCase
    • Simcyp™
    • D360™
    • SEND Explorer®
    • CoAuthor™
    • Chemaxon
  • Services
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1437 results found

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset Blog Post

Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul, SOUTH KOREA August 4rd –  Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today…

Drug Manufacturers’ Recent Drop in Insulin Prices in the United States Blog Post

The prevalence of diabetes in the US is incredibly high and affects more than 10% of the population. Patients living with diabetes rely on insulin to manage their blood sugar…

Certara and Drugs for Neglected Diseases initiative (DNDi) Partnering to Fast-track Data Submissions and Accelerate Drug Approvals for Neglected Patients Blog Post

DNDi Utilizing Pinnacle 21 Enterprise (P21E), Certara’s Data Science platform for Biostatistics, Data Management, and Data Standards to Streamline Clinical Data Flow PRINCETON, NJ/NAIROBI, KE, July 31, 2023 – Certara,…

ICER’s Unsupported Price Increase Report: Unfit for Policymaking Blog Post

Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported Price Increase (UPI) Report on its “assessment on drugs that experience significant price hikes without…

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling Blog Post

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on…

Simcyp™ Compound Summaries Library: What is it & why should you use it? Blog Post

In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files that serve as a vital component for accurate predictions for virtual clinical trials. Version 22…

RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission Blog Post

In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years…

Change Management – An Important Part of Good Manufacturing Practice (GMP) Blog Post

You are having a good day as a quality assurance professional at a small pharmaceutical company until you open an email from your company president asking for an explanation. She…

Certara to Report Second Quarter 2023 Financial Results on August 9th, 2023 Blog Post

PRINCETON, N.J.— July 13, 2023– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the second quarter of 2023 after the…

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?  Blog Post

Historically, the FDA has required drug discovery and development programs to include animal testing. With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical…

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