−Removed: We are a global leader in biosimulation technology and solutions for using Model-Informed Drug Development (“MIDD”) in the global biopharmaceutical industry.
−Removed: MIDD is an approach that utilizes biological and statistical models derived from preclinical and clinical data to inform decision-making in drug development and commercialization.
+Added: We are a global leader in biosimulation science, technology, and consulting services for using Model-Informed Drug Development (“MIDD”) in the global biopharmaceutical and biotech industry.
+Added: MIDD is an approach that utilizes biological and statistical models derived from preclinical, clinical, and evidence data to inform decision-making in drug research and development, and commercialization.
Biosimulation is a critical component of MIDD that uses computer-aided mathematical simulation of biological processes and systems to understand the action of a drug in a human body or a population of humans.
−Removed: Biosimulation and MIDD can increase the probability of success in bringing a new drug to market and decrease the costs of drug development.
−Removed: There are many examples of currently approved drugs where models were successfully used in discovery, preclinical, first-in-human dose predictions, clinical trial design, and for drug interaction label claims.
+Added: Biosimulation and hereby MIDD can increase the probability of success in bringing a new drug to market, accelerate its development and decrease the costs of drug development.
+Added: There are many examples of currently approved drugs where models were successfully used in discovery, preclinical, first-in-human dose predictions, clinical trial simulations and protocol design, and for drug interaction label claims.
Biosimulation is also used to support drug development beyond the approval stage;
examples include determining formulation or manufacturing changes and label extensions.
−Removed: In addition, MIDD strategies are increasingly utilized to help predict commercial success, a critical part of the drug development process as new products must be both approved by regulators and adopted by the market.
+Added: In addition, MIDD strategies are increasingly utilized to help predict commercial success, a critical part of the drug research and development process as new products must be both approved by regulators and adopted by the market.
The diagram below shows the different areas of expertise that come together to enable MIDD.
−Removed: Our organization has been purposefully designed to include all of these capabilities to collectively enable a new model of drug development for our clients.
−Removed: Our goal is to enable the life sciences industry to use data, modeling, and analytics to make better decisions during drug development and commercialization to increase productivity rates and vastly reduce development costs.
+Added: Our organization has been purposefully designed to include all these capabilities to collectively enable a new model of drug research and development for our clients.
+Added: Our goal is to enable the life sciences industry to use data, modeling, and analytics to make better decisions during drug research, development and commercialization to increase productivity rates and vastly reduce development costs.
The pharmaceutical industry spends more than $290 billion annually on research and development.
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Drug development is necessarily a highly regulated process involving the collection of vast amounts of laboratory, clinical and evidence data, and there are many failures at every step along the way that add to total cost.
−Removed: Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI, resulting in significant opportunities to decrease the cost and increase the odds of new drug approval and commercial success.
+Added: Our technology and scientists incorporate modern advances in scientific understanding, drug research and development experience, data analysis, and AI, resulting in significant opportunities to decrease the cost and increase the odds of new drug approval and commercial success.
+Added: Our approach to AI is grounded in our long-standing expertise in mechanistic and empirical modeling.
+Added: We deploy AI capabilities within validated scientific frameworks and expert-led workflows, rather than as standalone automated systems.
+Added: This expert-in-the-loop model allows us to leverage native AI capabilities in a manner that is consistent with regulatory expectations for transparency, reproducibility, and explainability.
Our proprietary biosimulation platforms are built on biology, chemistry, and pharmacology principles with proprietary mathematical algorithms that model how medicines and diseases behave in the body.
For over two decades, our scientists have developed and validated our biosimulation technology using data from scientific literature, laboratory research, preclinical and clinical studies.
−Removed: To do this, we have developed solutions for the collection, standardization, validation, storage, and analysis of the preclinical and clinical data needed for MIDD.
−Removed: These data solutions are used internally and by global life sciences companies.
−Removed: The scientific principles underlying our work must be transparent and fully explainable during the regulatory process, so we have developed expertise in incorporating data and results into regulatory documents.
−Removed: Our software and regulatory services streamline the creation of regulatory filings and speed regulatory data flow to maximize the chances of successful commercialization.
−Removed: AI and machine learning technologies are being incorporated across our software and services portfolios, providing opportunities to expand the number of data sources utilized, better predict outcomes, and streamline reporting.
−Removed: For example, we are using machine learning to automate and speed the process of biosimulation, and we have created an AI application to aid in drafting regulatory documents from scientific analyses and clinical data.
−Removed: We believe that AI predictive models will continue to enhance the accuracy and usefulness of biosimulation models and will be utilized broadly across drug development.
+Added: To do this, we have developed scientifically based solutions for the collection, standardization, validation, storage, and analysis of the preclinical, clinical and evidence data needed for MIDD.
+Added: These data solutions are used internally and industry wide by life sciences companies.
+Added: The scientific principles underlying our work must be transparent and fully explainable during the regulatory process, so we have developed expertise in incorporating data, references and results into regulatory documents.
+Added: Our software and regulatory scientific services streamline the creation of regulatory filings and speed regulatory data flow to maximize the chances of successful commercialization.
+Added: Native AI and machine learning technologies are being incorporated across our technology and consulting services portfolios, providing opportunities to expand the number of data sources utilized, better predict outcomes, and streamline reporting.
+Added: For example, we are using machine learning to automate and speed the process of biosimulation, and we have created generative AI applications to aid in drafting regulatory documents from scientific analyses and clinical data.
+Added: We apply AI capabilities within established modeling environments and under the supervision of experienced scientists and regulatory experts.
+Added: Our modeling platforms, curated datasets, and regulatory experience position us to incorporate emerging AI techniques in a controlled and scientifically rigorous manner.
+Added: While AI can enhance productivity and insight generation, our solutions continue to rely on validated models and expert interpretation to support decision-making in regulated environments.
We leverage our validated software applications to deliver technology-enabled services.
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We have worked with more than 2,600 life sciences companies and academic institutions and have collaborated on more than 10,000 customer projects in the last decade across a wide variety of therapeutic areas ranging from cancer and hematology to diabetes and hundreds of rare diseases.
−Removed: Our software products are licensed by more than 94,000 users and are also used by 23 global drug regulatory agencies, including the FDA, Japan’s Pharmaceuticals and Medical Devices Agency (the “PMDA”), and China’s National Medical Products Administration (the “NMPA”).
+Added: Our software products are licensed by more than 160,000 users and are also used by 20 global drug regulatory agencies, including the FDA, Japan’s Pharmaceuticals and Medical
+Added: Devices Agency (the “PMDA”), and China’s Center for Drug Evaluation (the “CDE”) within the National Medical Product Administration (the “NMPA”).
Our Solutions
−Removed: We offer differentiated and comprehensive solutions for MIDD, which include software and technology-enabled services.
−Removed: Customers use our solutions to implement MIDD with the aim of improving certainty, accuracy, commercial success and the speed at which decisions can be made during the drug development process.
+Added: We offer differentiated and comprehensive solutions for MIDD, which include science, technology and consulting services.
+Added: Customers leverage our solutions to implement MIDD with the aim of improving certainty, accuracy, commercial success and the speed at which decisions can be made during the drug research and development process.
+Added: Our AI capabilities are unified into this broader modeling and regulatory framework.
+Added: Unlike general-purpose AI tools, our applications are designed to operate within scientific data environments and established pharmacometric and regulatory methodologies.
+Added: This integration reflects our view that AI is most effective when combined with domain expertise (“expert-in-the-loop”), validated models, and regulatory-grade data processes.
Life sciences companies make many decisions during the MIDD process that have regulatory considerations.
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In addition, recognizing that time to approval is one of the most valuable components of the drug development journey, we designed our regulatory solutions to accelerate the regulatory writing and filing process.
−Removed: By offering both software and services solutions, we provide flexible offerings for life sciences companies of all sizes and requirements.
+Added: By offering science, technology and consulting services solutions, we provide flexible offerings for life sciences companies of all sizes and requirements.
Services are complemented by scientific and regulatory expertise to conduct and interpret biosimulation results and make recommendations on the next best action to move a program forward.
In 2023, we extended the capabilities of MIDD and regulatory offerings with the launch of an AI platform designed for life sciences, Certara.AI.
−Removed: Certara.AI is a secure, flexible platform for deploying life science-specific Generative Pre-Trained Transformers (“GPTs”) across an organization’s data, enabling faster search, connectivity, and content generation.
+Added: Certara.AI is a secure, scalable, reliable and flexible platform for deploying life science-specific Generative Pre-Trained Transformers (“GPTs”) across an organization’s data, enabling faster search, connectivity, and content generation.
Additionally, in 2024, we launched the next generation of our CoAuthor regulatory writing software, which combines generative AI, data integration, and structured content authoring tools to enable writers to create and assemble regulatory submissions and medical publications faster and with confidence in the quality of their results.
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Mechanistic biosimulation models are built by experts using known scientific principles and facts, while empirical biosimulation solutions are typically statistical models built using preclinical and clinical data.
−Removed: Our customers use biosimulation results to improve the design of clinical trials, reduce trial size and complexity, and in some cases obtain clinical trial waivers to replace clinical testing.
+Added: Our customers use biosimulation results to simulate clinical trials, to improve the design of clinical trials, reduce trial size and complexity, and in some cases obtain clinical trial waivers to replace clinical studies.
Simcyp Simulator
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The Simcyp Simulator has been applied to small molecules, biologics, antibody-drug conjugates (“ADCs”), generics, and new modality drugs.
−Removed: Simcyp was started over 20 years ago and has been expanded each year with extensions and additions to its biosimulation models and is designed to produce “regulatory quality” results that customers can use in their drug approval applications.
+Added: Simcyp was started over 20 years ago and has been expanded each year with extensions and additions to its
+Added: biosimulation models and is designed to produce “regulatory quality” results that customers can use in their drug approval applications.
The Simcyp Simulator family includes various add-on modules, as well as products focused on specific aspects of drug development that can benefit from its mechanistic simulation approach.
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Phoenix has four modules that support pharmacometrics and workflow.
−Removed: • Phoenix WinNonlin – A platform for non-compartmental analysis, PK/PD, and TK modeling with a proven 30-year history and extensive use across the biopharmaceutics industry.
−Removed: • Phoenix Hosted – A hosted (i.e., online) version of Phoenix, which provides a secured and validated Certara Amazon Web Services (“AWS”) workspace allowing for much quicker transit time from compliant data sources.
+Added: • Phoenix WinNonlin – A platform for non-compartmental analysis, PK/PD, and TK modeling with a regulatory proven 30-year history and extensive use across the biopharmaceutics industry.
+Added: • Phoenix Cloud – Our next generation cloud version of Phoenix, which provides a secured and validated Certara Amazon Web Services (“AWS”) workspace allowing for much quicker transit time from compliant data sources.
It enhances productivity and supports compliance requirements by managing complex time-based drug data, the foundation for all PK/PD modeling.
• Phoenix NLME – A population modeling and simulation software for nonlinear mixed effects (“NLME”) models, a type of pharmacometric model often used by pharmacometricians to model absorption effects.
−Removed: • Pirana Modeling Workbench – A workbench providing modelers with a structure to facilitate the iterative processes used to create population PK/PD models and perform simulations using AI and machine learning resulting in more efficient analysis.
+Added: • Pirana Modeling Workbench – A workbench providing modelers with a structure to facilitate the iterative processes used to create population PK/PD models and perform simulations using AI and machine learning resulting in more efficient model selection and analysis.
Scientific Informatics for Improving Drug Discovery and In-Silico Development
In 2024, Certara acquired Chemaxon, a software company that develops leading software products for chemical property prediction, search, and analysis.
−Removed: Used by research scientists globally, Chemaxon software helps to digitize the design, make, test and analyze lifecycle to discover the best new chemical leads.
+Added: Used by research scientists globally, Chemaxon software helps to digitize the design, make, test and analyze discovery lifecycle to select the best new chemical leads.
Certara and Chemaxon have had a long-term partnership spanning ten years, providing integrated solutions to the life sciences industry.
−Removed: The acquisition strategically positions Certara in the drug discovery biosimulation market and is intended to complement Certara’s existing biosimulation portfolio which is widely used in later phases of drug development.
+Added: The acquisition strategically positions Certara in the drug discovery biosimulation market and
+Added: complement Certara’s existing biosimulation portfolio which is widely used in later phases of drug development.
Together, Certara and Chemaxon offer life sciences companies a more complete data and predictive analytics platform, helping to advance the decision-making from discovery through commercialization.
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Chemaxon Compound Registration – Compound Registration supports a streamlined lead optimization process workflow by comparing the uniqueness of new small molecules against those already stored in a database.
−Removed: Chemaxon Design Hub – A compound design and tracking platform for drug discovery teams and their external collaborators that connects scientific hypotheses, candidate compound selection and computational capabilities.
−Removed: Design Hub has been integrated with the Certara D360 solution for more than eight years to provide an optimal end user experience throughout the lead optimization stage of discovery.
−Removed: Certara D360™ Software – D360 is a scientific informatics system for small molecule and biologics discovery research.
−Removed: It provides researchers with self-service data access, integrated data visualizations, analysis and collaboration tools for prioritization, development of Structure Activity Relationship (“SAR”) and many other scientific data workflows to improve the effectiveness of data-driven research.
+Added: The application is foundational to manage IP for the life science industry.
+Added: Chemaxon Design Hub – A compound design and tracking platform for drug discovery teams and their external collaborators that connects workflows for scientific hypotheses, candidate compound selection and computational capabilities.
+Added: Design Hub has been integrated with the Certara D360 solution for more than eight years to provide optimal end user experience throughout the lead optimization stage of discovery.
+Added: Certara D360 Software – D360 is a scientific informatics application for small molecule and biologics discovery.
+Added: It provides researchers with industry leading self-service data access, comprehensive data visualizations, analysis and collaboration tools for prioritization, development of Structure Activity Relationship (“SAR”) and many other scientific data workflows to improve the effectiveness of data-driven research.
Chemaxon Marvin – Marvin is a universal chemical drawing tool for chemists involved in research and drug discovery.
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Our principal clinical data suite is the Pinnacle 21 family of products.
−Removed: • Pinnacle 21 – A cloud-based platform for clinical data automation, standardization, and validation with industry standards.
+Added: • Pinnacle 21 – A cloud-based application for clinical data collection, standardization, and validation with industry standards.
Pinnacle 21 is widely utilized across the pharmaceutical industry and by its regulators to validate that clinical data meets the required standards for regulatory submittal.
−Removed: We support two versions of Pinnacle 21 – a fully featured enterprise version, which contains workflow and reporting tools needed by large-scale drug development customers, and a more basic free community version designed for small organizations who want to try the software.
−Removed: • Pinnacle 21 Data Exchange – Allows sponsors and data providers to define data standards and specifications (metadata) and ensure that data adheres to these specifications to make the process of acquiring external data from laboratory and clinical sources more efficient and predictable.
−Removed: • Metadata Repository – A cloud-based Clinical Metadata Repository & Study Data Tabulation Model automation suite to enable faster study design using controlled and standardized data.
+Added: We support two versions of Pinnacle 21 – a fully featured enterprise version, which contains workflow and reporting tools needed by commercially targeted drug development projects, and a more basic free community version designed for organizations who want to try the software.
+Added: • Pinnacle 21 Data Exchange – Allows sponsors and data providers to define data standards and specifications (metadata) and ensure that collected clinical data adheres to these specifications to make the process of acquiring external data from laboratory and clinical sources more efficient and predictable.
+Added: • Metadata Repository – A cloud-based Clinical Metadata Repository & Study Data Tabulation Model automation suite to enable faster transformation from protocol study design using controlled and standardized metadata and setting up the clinical study to produce faster time to analysis resulting in more successful clinical trials.
Regulatory Science
−Removed: Our comprehensive regulatory science solutions help provide our customers the coordinated technology-enabled regulatory submission and regulatory writing expertise they need to accelerate the regulatory writing and filing process.
+Added: Our comprehensive regulatory science solutions provide our customers the coordinated technology-enabled regulatory submission and regulatory writing expertise they need to accelerate the regulatory writing and filing process.
• CoAuthor Software – Structured and Assisted Content Authoring with Generative AI – Approval for a new drug or biologic requires expert development of numerous regulatory documents, which is a time intensive process often requiring inputs from a variety of data sources and types.
−Removed: CoAuthor powers efficient and expedited creation of regulatory documents and medical communications.
−Removed: Combining data integration, structured content authoring and AI, CoAuthor enables writers to create and assemble regulatory submissions and medical publications faster and with confidence in the quality of their results.
−Removed: • GlobalSubmit™ eCTD Submissions Management – T he Electronic Common Technical Document (“eCTD”) is a standard format required for submitting applications to regulatory authorities.
−Removed: GlobalSubmit eCTD submissions management software provides regulatory teams with the tools they need to efficiently publish, validate, and review eCTD submissions.
+Added: CoAuthor powers efficiently and expedited creation of regulatory documents and medical communications.
+Added: Combining data integration, structured content authoring and generative AI, CoAuthor enables writers to create and assemble regulatory submissions and medical publications faster and with confidence in the quality of their results.
+Added: • GlobalSubmit eCTD Submissions Management – The Electronic Common Technical Document (“eCTD”) is a standard format required for submitting applications to regulatory authorities.
+Added: Our GlobalSubmit eCTD submissions management software provides regulatory teams with the tools they need to efficiently review, validate, and publish eCTD submissions.
Technology-Enabled Services
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One of the most scientifically innovative areas of biosimulation is QSP, an approach which combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process.
−Removed: We believe that Certara has one of the largest teams of QSP experts in the pharmaceutical industry.
−Removed: The insights delivered by our QSP team help answer critical questions about novel therapies required for development progression, including “which drug candidate is optimal” and “which patient populations are most likely to respond.”
−Removed: We have differentiated our approach to QSP by building robust, regulatory-ready software platforms for reproducible model development that are further enabled by Certara.AI.
+Added: We believe that Certara has one of the largest teams of QSP experts in the life science industry.
+Added: The insights delivered by our QSP scientist help answer critical questions about novel therapies required for development progression, including “which drug candidate is optimal” and “which patient populations are most likely to respond.”
+Added: We have differentiated our approach to QSP by building robust, regulatory-ready software platforms (Certara IQ) for reproducible model development that are further enabled by Certara.AI.
Currently, QSP platforms are available for immunogenicity, immuno-oncology, and capabilities for neurodegenerative diseases are in development.
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Drug Development and Regulatory Strategy :
−Removed: Our experts develop and deliver drug development and regulatory plans and provide high-level regulatory input to customer projects, incorporating biosimulation and supporting decision making through critical development and investment stage gates.
+Added: Our scientific experts develop and deliver drug development and regulatory plans and provide high-level regulatory input to customer projects, incorporating biosimulation and supporting decision making through critical development and investment stage gates.
Pharmacometrics:
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As the volume, variety, and velocity of data available in research has grown rapidly, so has the complexity of collecting, analyzing, and publishing data.
−Removed: Certara offers biometrics and data sciences services to help clients analyze and standardize data for faster time to insight and for submission readiness, in addition to preparing and transforming data for use in biosimulation and pharmacometrics models.
+Added: Certara offers biometrics and data sciences services to
+Added: help clients analyze and standardize data for faster time to insight and for submission readiness, in addition to preparing and transforming data for use in biosimulation and pharmacometrics models.
Clinical Pharmacology:
−Removed: Certara has numerous industry leaders and experts that guide drug developers in clinical pharmacology decisions.
+Added: Certara has numerous industry leaders and scientific experts that guide drug developers in clinical pharmacology decisions.
They provide early-phase development plans and study designs across the development life cycle, often incorporating biosimulation along with regulatory support.
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Regulatory Operations:
−Removed: We manage the submission of regulatory documents using our GlobalSubmit platform.
+Added: We manage the submission of regulatory documents using our Global Submit platform.
Submission management services include submission leadership, program management and planning, due diligence and readiness preparation, submission compilation, and eCTD publishing using Global Submit.
Certara supports applications to all major health agencies, including the FDA, the European Medicines Agency (the “EMA”), Health Canada, Japan’s PMDA, and China’s NMPA.
−Removed: Our markets within the biopharmaceutical industry are large and growing.
−Removed: Traditional drug discovery and development is costly and prone to failure.
+Added: Our markets within the life science industry are large and growing.
+Added: Traditional research and development is costly and prone to failure.
The biopharmaceutical industry was estimated to have spent a total of approximately $290 billion in 2025 on R&D.
−Removed: Currently, over 90% of drug candidates fail during the drug development process, many after significant expenditures of resources and time.
+Added: Currently, over 90% of drug candidates fail during the research and development process, many after significant expenditures on resources and time.
We believe that biosimulation solutions can improve these success rates.
A small percentage increase in success rates has a large impact on the costs of the overall system;
−Removed: research shows that a modest increase of just three percent in the success rates at each development phase could save almost three hundred million dollars in total costs per approved drug.
+Added: research shows that a modest increase of just three percent in the success rates at each life cycle phase could save almost three hundred million dollars in total costs per approved drug.
Additionally, there are often new ways that biosimulation is used to create value as the simulation and modeling capabilities are constantly expanding.
−Removed: With increasing adoption of technology across all stages of drug discovery and development, we believe our end-to-end platform and growth strategies position us to further penetrate the rapidly growing technology-driven biopharmaceutical R&D market of the future that leverages advanced modeling and analytics.
+Added: With increasing adoption of technology across all stages of research and development, we believe our end-to-end platform and growth strategies position us to further penetrate the rapidly growing technology-driven life science R&D market of the future that leverages advanced modeling, simulation and analytics.
With greater investment dollars being spent and increasing competition in the race to develop novel medicines, the speed and efficiency with which drugs are developed and brought to market have never been more critical.
−Removed: As a result, the demand for and willingness to adopt innovative approaches to discovery, development, and commercialization are rapidly increasing.
−Removed: Continued development and innovation in software and technology such as biosimulation, virtual trials, and real-world evidence tools are helping biopharmaceutical companies increase efficiency and decrease costs.
+Added: As a result, the demand for and willingness to adopt innovative approaches to research, development, and commercialization are rapidly increasing.
+Added: Continued innovation in technology such as biosimulation, virtual trials, and real-world evidence applications are helping biopharmaceutical and biotech companies increase efficiency and decrease costs.
This is further bolstered by regulatory agencies that have increasingly issued guidance supporting the adoption of many of these innovations.
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Biosimulation’s use cases in dose finding and optimization are well-suited to help biopharmaceutical companies navigate this evolving regulatory landscape.
−Removed: As technology and analytics become increasingly powerful along with AI and the application of new solutions is validated, we anticipate further demand for these innovations.
−Removed: We believe we are still in the early stages of a long-term trend that will continue to advance traditional drug discovery and development into a technology-driven era of advanced modeling, analytics, and AI enabled solutions.
+Added: As technology become increasingly powerful with AI and the application of new solutions is validated, we anticipate further demand for innovation.
+Added: We believe we are still in the early stages of a long-term trend that will continue to advance traditional research and development into a technology-driven era of advanced modeling, simulations, analytics that are dramatically enhanced using AI enabled capabilities.
Our Growth Strategy
−Removed: Our growth strategy is to build upon our platforms creating more value through increased automation and connectivity.
−Removed: We continue to innovate in biosimulation, develop more AI-enabled offerings across our portfolio, engage with regulatory agencies, and land and expand our customer relationships.
+Added: Our growth strategy is to build upon our science, technology and consulting services creating more value through increased certainty and speed in decisions making.
+Added: We continue to lead innovation in biosimulation, through successful engagement with our customers regulatory agencies, and though leadership with academic and similar constituents.
+Added: Our investment in AI is focused on enhancing modeling productivity, improving data connectivity across our platform, and supporting scientific decision-making.
+Added: We prioritize integration of AI into existing validated workflows and seek to ensure that new capabilities align with scientific best practices and regulatory requirements.
We remain focused on reducing the cost, time, and probability of failure of clinical trials for our customers so that they may potentially accelerate and lower overall cost of the delivery of future therapies that are needed by patients worldwide.
−Removed: As new research and technologies areas and opportunities arise, we seek to attract and hire specialized talent and acquire complementary businesses to expand our offerings accordingly.
+Added: As new scientific research and technologies areas and opportunities arise, we seek to attract and hire specialized talent and acquire complementary businesses to expand our offerings accordingly.
Advance Our Technology
−Removed: The science, technology, and data behind biosimulation continue to advance rapidly, and our top investment priority is to develop additional functionality and uses for biosimulation to improve decision making and patient outcomes.
−Removed: We aim to release new software, additional features, and upgrades on a frequent and regular basis, with a focus on cloud-based solutions, as a means to integrate and connect access to our products within an end-to-end platform.
−Removed: In 2024, we introduced 36 new software applications and upgrades, including Phoenix Version 8.5, next-generation CoAuthor and Certara Cloud.
+Added: The science, technology, and consulting services behind biosimulation continue to advance rapidly, and our top investment priority is to develop additional capabilities and uses for biosimulation to improve certainty in decision making and eventually patient outcomes.
+Added: We aim to release new software, additional features, and upgrades on a frequent and regular basis, with a focus on cloud-based solutions, to integrate and connect access to our products within an end-to-end platform.
+Added: In 2025, we introduced 103 new software applications and upgrades, including Phoenix Cloud's AI PK reports module, Pinnacle 21 Enterprise Plus, and Certara IQ.
Grow Within Our Existing Customer Base
−Removed: As we continue to expand our portfolio of offerings, we integrate our solutions and sell more across our end-to-end platform.
−Removed: We actively cross-sell our software and technology-enabled services throughout our end-to-end platform.
−Removed: Our scientists and regulatory and market access experts, business developers, marketing professionals, and business leaders work together to provide a high-quality customer experience and nurture long-term partnerships.
−Removed: Ultimately, one of our goals is to facilitate customer growth over time through higher adoption of biosimulation with additional user licenses and more modules.
+Added: As we continue to expand our portfolio of offerings, through our unique blend of science, technology and consulting services.
+Added: We actively engage with our customers to up- and cross-sell our solutions.
+Added: Our scientists,regulatory and market access experts, business developers, marketing professionals, and business leaders work together to provide a high-quality customer experience and nurture long-term partnerships.
+Added: Ultimately, one of our goals is to facilitate customer growth over time through higher adoption of biosimulation.
Expand Our Customer Base Globally
−Removed: We have invested in an international footprint to effectively serve the global biopharmaceutical industry.
−Removed: There are more than 5,500 biopharmaceutical companies worldwide with active R&D pipelines as of January 2023, up from nearly 2,400 in 2011.
+Added: We have continuously invested in an international footprint to effectively serve the global biopharmaceutical and biotech industry.
+Added: There were more than 6,800 biopharmaceutical companies worldwide with active R&D pipelines in 2025, up from nearly 2,400 in 2011.
As of December 31, 2025, we had employees in 28 countries, including approximately 585 in the US, 707 in Europe, and 177 in Asia.
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Part of our strategy to date has been to pursue strategic acquisitions to accelerate our development roadmap.
−Removed: Since 2013, we have acquired 21 companies, 14 of which include software or technology, with such key acquisitions including Simcyp, the core of our mechanistic biosimulation platform, Pinnacle 21, which enhances our software offerings in data management and the regulatory drug approval process, and Vyasa TM , which brings state-of-the-art AI capabilities to our end-to-end platform.
+Added: Since 2013, we have acquired 21 companies, 14 of which include software or technology, with such key acquisitions including Simcyp, the core of our mechanistic biosimulation platform, Pinnacle 21, which enhances our software offerings in data management and the regulatory drug approval process, and Vyasa, which brings state-of-the-art AI capabilities to our end-to-end platform.
More recently, in 2023, we also acquired Formedix, which added a metadata repository and clinical data flow automation to our data platform, and Applied Biomath, a company focused on QSP to expand and complement our existing QSP capabilities.
−Removed: In 2024, we acquired Chemaxon, a leading provider of cheminformatics software to expand and complement our existing prediction and analytical capabilities in drug discovery.
+Added: In 2024, we acquired Chemaxon, a leading provider of scientific informatics software to expand and complement our existing prediction and analytical capabilities in drug discovery.
Our Customers
−Removed: Our customers include life sciences companies of all sizes along with contract research organizations, academic institutions, and global regulators.
−Removed: Certara software and services have been used by more than 2,400 biopharmaceutical companies and academic institutions across 70 countries, including 38 of the top 40 biopharmaceutical companies by R&D spend in 2023.
+Added: Our customers include life sciences companies of all sizes along with contract research organizations, academic and government institutions, and global regulators.
+Added: Certara science, technology and consulting services have been used by more than 2,600 biopharmaceutical and biotech companies and academic institutions across 70 countries, including 38 of the top 40 biopharmaceutical companies by R&D spend in 2025.
We also derive limited revenue from contracts with U.S.
−Removed: government agencies, including the FDA and the Center for Disease Control and Prevention within the Department of Health and Human Services, as well as foreign governments.
−Removed: For example, our software products are licensed by 23 global drug regulatory agencies, including the FDA, Health Canada, Japan’s PMDA, China’s NMPA and the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”).
+Added: government agencies, including the FDA and the U.S.
+Added: Department of Health and Human Services (DHHS), as well as some foreign governments.
+Added: For example, our software products are licensed by 20 global drug regulatory agencies, including the FDA, EU’s EMA, Japan’s PMDA, China’s CDE within the NMPA and the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”).
In addition to life sciences, Certara serves customers in animal health, crop science, bio science, medical devices, and public sector industries.
No single customer accounted for more than 10% of our revenues in 2025.
−Removed: Our ten largest customers accounted for 27% and 28% of revenues for each of the years ended December 31, 2024 and 2023, respectively.
+Added: Our ten largest customers accounted for 24% and 27% of revenues for the years ended December 31, 2025 and 2024, respectively.
Sales and Marketing
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Our global commercial team collaborates with our scientists, subject matter experts, and technologists to engage with customers and prospects to understand their needs and offer tailored solutions with our biosimulation software and technology-enabled services.
−Removed: In support of our presence and authority within our fields, our scientists and experts have authored thousands of scientific
−Removed: publications, posters, and articles to share biosimulation knowledge and methods to advance adoption.
−Removed: Additionally, in an effort to further expand our reach to potential customers, we may partner with software distributors in regions or categories where we may have less dedicated presence or activity today.
+Added: In support of our presence and authority within our fields, our scientists and experts have authored thousands of scientific publications, posters, and articles to share biosimulation knowledge and methods to advance adoption.
+Added: Additionally, to further expand our reach to potential customers, we may partner with software distributors in regions or categories where we may have less dedicated presence or activity today.
The market for our biosimulation products and related services for the biopharmaceutical industry is competitive and highly fragmented.
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In addition to competition from other solution providers, another challenge is that some biopharmaceutical industry participants may still rely on or over-index the status quo method of conducting research without fully leveraging the benefits of modeling, simulation, AI, dataflow and analytics platforms to inform and de-risk decisions across each phase of research and development.
−Removed: In our view, the principal competitive factors in our market are the functionality and quality of models, the breadth of molecular types, therapeutic areas, and modalities supported, regulator acceptance of our solutions, ease of use and functionality of applications, depth of experience in drug development, brand awareness and reputation, total cost, and the ability to securely integrate with other enterprise applications and the overall drug development process in the customer.
+Added: We believe our combination of scientific modeling expertise, regulatory experience, and technology enablement differentiates us from both general-purpose AI technology providers and point-solution modeling tools.
+Added: While AI capabilities are increasingly available across the industry, effective application in regulated drug development requires domain knowledge, validated methodologies, and expert oversight.
+Added: We believe our scientific teams and long-standing modeling platforms position us well to incorporate and operationalize AI advances in this context.
+Added: In our view, the principal competitive factors in our market are the functionality and quality of models, the breadth of molecular types, therapeutic areas, and modalities supported, regulator acceptance of our solutions, ease of use and functionality of applications, depth of experience in drug development, brand awareness and reputation, total cost, and the ability to securely integrate with other enterprise applications and the overall drug research and development process in the customer.
We believe that we compete favorably based on these factors and that the time, effort, and investment necessary to develop validated models, modeling solutions, enterprise software and extensive MIDD experience presents a significant barrier to new entrants.
−Removed: Our ability to remain competitive depends on our ability to continue to invest in innovation as MIDD and drug development science advances.
+Added: Our ability to
+Added: remain competitive depends on our ability to continue to invest in innovation as MIDD and drug development science advances.
In the biosimulation software market, we compete with other technology companies including Mathworks, Dassault Systemes, Ansys, Simulations Plus, and NONMEM, a division of ICON.
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Additionally, we compete with other specialized service providers including Metrum Research, qPharmetra, and Pharmetheus.
−Removed: We compete in both the biosimulation software market and technology-enabled services markets, with outcomes typically based on the quality and capabilities of our products, our scientific, technical and regulatory expertise, our ability to innovate and develop solutions attractive to customers, our regulatory agency partnerships, and price, among other factors.
+Added: We compete in both the biosimulation software market and technology-enabled services markets, with outcomes typically based on the quality and capabilities of our products, our scientific, technical and regulatory expertise, our ability to innovate and develop attractive solutions to customers, our regulatory agency partnerships, and price, among other factors.
Intellectual Property
−Removed: We safeguard and enhance our innovative technology platforms, systems, processes, and databases with a full array of intellectual property rights, including copyrights, trade secrets, know-how, patents, and tradenames/trademarks.
−Removed: Our proprietary software products are copyright protected, and may be further defined by contractual provisions in our software license agreements limiting permitted uses and also prohibiting specific acts of infringement, such as reverse engineering, deriving, or otherwise using the source code and underlying algorithms in all cases or beyond the terms of a license, as the case may be.
−Removed: Embedded within some of our biosimulation tools, including the Simcyp Simulator, are several decades’ worth of proprietary data that have been compiled and collated from both public and private sources.
−Removed: These data, in tandem with our proprietary source code and algorithms, create powerful modeling tools that cannot be easily or practically duplicated independently.
−Removed: Continual ongoing development of source code and algorithms as well as new version release of modeling tools also contribute to the competitive value of our proprietary software products.
−Removed: Our processes and systems are further protected by trade secrets principles and expert knowledge bases, which we seek to secure by requiring and enforcing confidentiality obligations with our employees, contractors, customers, and other third parties, and invention assignment agreements with our employees, in collaboration with administrative and technical safeguards.
−Removed: We maintain a portfolio of issued and pending patents in several jurisdictions in which we do business.
−Removed: As of December 31, 2024, our patent portfolio consists of 29 issued patents, which expire and may be renewed by us on a rolling basis as available and determined by us, between November 2026 and August 2044, and 16 pending patent applications related to our software and technology.
+Added: We protect our technology platforms, systems, processes, and databases through a comprehensive set of intellectual property rights, including copyrights, trade secrets, know-how, patents, and trademarks.
+Added: Our proprietary software products are protected by copyright and further safeguarded through the terms of our software license agreements, which limit authorized uses and prohibit activities such as reverse engineering, decompiling, or accessing source code or underlying algorithms except as expressly permitted.
+Added: Several of our biosimulation tools, including the Simcyp Simulator, incorporate proprietary datasets compiled over decades from both public and private sources.
+Added: These datasets, combined with our proprietary source code and algorithms, form advanced modeling capabilities that cannot be readily replicated.
+Added: Ongoing enhancements to our source code and algorithms, as well as periodic releases of updated modeling tools, further strengthen the competitive value of our software products.
+Added: We also protect our processes, systems and internal methodologies through trade secret principles and specialized institutional knowledge.
+Added: To safeguard this information, we require and enforce confidentiality obligations with employees, contractors, customers, and other third parties, and we enter into invention-assignment agreements with our employees.
+Added: These contractual protections alongside our administrative and technical safeguards work to preserve the integrity of our intellectual property and confidentiality of our trade secrets.
+Added: We maintain a portfolio of issued patents and pending applications in several jurisdictions in which we do business.
+Added: As of December 31, 2025, our patent portfolio included 22 issued patents, set to expire between November 2026 and October 2040, as well as 17 pending patent applications related to our software and technology.
+Added: These patents and applications may be renewed by us as deemed necessary.
We do not currently consider any of our issued patents to be independently material to our business.
−Removed: We maintain registration in the United States and other countries for numerous trademarks, including Certara, Simcyp, Phoenix, Pinnacle 21, Virtual Twin, WinNonlin, Vyasa, and BaseCase.
+Added: We maintain registration in the United States and other countries for numerous trademarks, including Certara, Simcyp, Phoenix, Pinnacle 21, Virtual Twin, WinNonlin, Vyasa, Chemaxon, and BaseCase.
We pursue trademark registrations to the extent we believe doing so would be beneficial to our competitive position.
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We are a global team united in our purpose to accelerate medicine to patients.
−Removed: Challenging the status quo, our talented team of scientists, software developers, and subject matter experts strive to understand our customers’ most difficult business challenges and apply cutting edge technology and rigorous scientific thinking to inform solutions.
+Added: Challenging the status quo, our talented team of scientists, software developers, and subject matter experts strive to understand our customers’ most difficult business challenges and apply cutting edge technology and rigorous scientific thinking to inform
As of December 31, 2025, we employed 1,576 professionals in 28 countries, including 1,515 full-time employees and 61 part-time employees, of which 414 held PhD or Doctor of Medicine degrees in their respective disciplines, including clinical pharmacology and pharmacometrics.
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We also rely on independent contractors to address discrete parts of our business and provide expertise in certain specialized areas or focus on projects.
+Added: We also rely on independent contractors to address discrete parts of our business and provide expertise in certain specialized areas or focus on projects.
In 2025, we again received the “Great Place to Work” award (from the Great Place to Work® Institute, Inc.).
−Removed: Our over 1,500 employees are the key to our success.
+Added: Our employees are the key to our success.
The breadth and depth of expertise, experience, and backgrounds fuel innovation by bringing rich ideas, problem-solving capabilities, and mutual respect.
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We seek to offer our people competitive compensation packages, depending on role or market, and varying by location we may make available on group terms pension/retirement savings programs, benefits, life insurance, income protection, and healthcare offerings.
−Removed: We strive to provide all staff opportunities for career advancement by posting and announcing openly all promotion opportunities, regularly reviewing pay to ensure fair practices and providing training to all new hires.
+Added: We strive to provide all staff opportunities for career advancement by posting and announcing openly all promotion opportunities, regularly reviewing pay to ensure fair practices and providing training for all new hires.
Government Regulation
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Although our biosimulation software products and platforms are not approved by the FDA or other government agencies, our customers’ products are subject to these regulations, which may be applicable to us to the extent that the services and deliverables we provide to our customers are used in their marketing applications.
−Removed: Consequently, we must
−Removed: comply with relevant laws and regulations relating to certain aspects of the drug and biologic development and approval process.
+Added: Consequently, we must comply with relevant laws and regulations relating to certain aspects of the drug and biologic development and approval process.
For example, our customers may require that documents or records we produce that may be used in the approval process be compliant with part 11 of Title 21 of the U.S.
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Privacy and Cybersecurity Laws
−Removed: The collection, use, disclosure, disposal, protection, and other processing of information about individuals, in particular healthcare data, is highly regulated both in the U.S., EU and other jurisdictions, including but not limited to:
+Added: The collection, use, disclosure, disposal, protection, and other processing of information about individuals, in particular healthcare data, is highly regulated both in the U.S., EU and other jurisdictions, including but not
Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and other U.S.
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The GDPR and the UK’s post-Brexit equivalent of the GDPR (“UK GDPR”) is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive personal data, cross-border transfers, notice and consent and contractual obligations with vendors and service providers.
−Removed: Data protection authorities are authorized to impose
−Removed: large administrative penalties for violations of the GDPR or UK GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater, for each law.
+Added: Data protection authorities are authorized to impose large administrative penalties for violations of the GDPR or UK GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater, for each law.
Legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States, including the European Commission’s adequacy decision with respect to the transfer of personal data from the EU to the United States and establishment of the EU-U.S.
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Concurrently, we observe a trend toward expanding privacy data protection law both in number and scope that will expand our obligations.
−Removed: We may need to modify our practices and incur expenses to accommodate this evolving privacy compliance landscape.
+Added: may need to modify our practices and incur expenses to accommodate this evolving privacy compliance landscape.
Bribery, Anti-Corruption and Other Laws
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.