Certara

Certara is a leading drug development solutions company that integrates science, technology, strategic expertise, and regulatory knowledge to help organizations bring medicines from molecule to market more efficiently. Serving biotech companies, large pharmaceutical organizations, and contract research organizations (CROs), Certara combines data-driven modeling, artificial intelligence, and predictive simulation to accelerate the drug development process and improve decision-making at every stage.

The company's comprehensive portfolio spans the full drug development lifecycle — from early discovery and preclinical research through clinical development, regulatory submission, and commercial market access. By breaking down organizational silos and streamlining workflows, Certara enables its customers to reduce development risk, optimize trial design, and achieve regulatory success with greater speed and confidence.

Software Solutions

• Phoenix® — Provides pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic analysis and modeling capabilities.
• Simcyp® — Uses advanced physiologically based pharmacokinetic (PBPK) modeling and simulation to predict drug behavior across diverse patient populations.
• Pinnacle 21® — Supports data standardization and validation to ensure submission-ready datasets meet regulatory requirements.
• Certara IQ™ — Integrates biological and pharmacological insights to optimize predictions of drug efficacy and safety.
• GlobalSubmit™ — Enables teams to publish, review, and transmit eCTD regulatory submissions.
• BaseCase® — Helps teams communicate interactive, data-driven value stories for market access and commercial purposes.
• SEND Explorer® — Visualizes nonclinical study data to identify trends and outliers.
• D360™ — Delivers scientific informatics capabilities to access, analyze, and visualize molecule and bioactivity data.
• Certara.AI — An AI platform purpose-built for the life sciences industry.
• CoAuthor™ — Leverages generative AI, templates, and structured content to streamline regulatory writing.
• Chemaxon — Enhances scientific discovery through chemical and biological intelligence tools.

Solutions by Development Phase

• Regulatory — Helps organizations navigate complex regulatory landscapes using tailored strategies and AI-driven tools, including the Non-Animal Navigator™ for alternative approaches to traditional testing.
• Model-Informed Drug Development (MIDD) — Reduces development risk and accelerates key decisions through predictive science and model-informed strategies.
• Discovery — Accelerates breakthroughs by applying biosimulation and modeling to refine drug candidates and improve go/no-go decisions.
• Preclinical — Streamlines IND submissions with predictive modeling and dosing optimization.
• Early Clinical — Supports first-in-human success through advanced simulation and precision dosing strategies.
• Late Clinical — Delivers robust, regulatory-ready data while optimizing trial design and supporting commercial planning.
• Market Access & Commercial — Helps organizations demonstrate product value and optimize pricing strategies to improve global patient access.

Services Offerings

• Modeling and Simulation — Applies predictive biosimulation and modeling to inform dosing, safety, and efficacy decisions throughout development.
• Biometrics and Data Science — Delivers submission-ready datasets and analyses through advanced programming, validation, and data standardization.
• Drug Development Support — Provides tailored, MIDD-driven strategies across all development phases to optimize execution and decision-making.
• Regulatory and Medical Communications — Ensures global compliance and produces impactful medical narratives through expert regulatory documentation and strategy.
• Real World Evidence and Market Access — Leverages real-world data to build value propositions, engage payers, and secure market access.
• Therapeutic Specialties — Centers of Excellence offering specialized expertise in complex therapeutic areas including oncology, pediatrics, and rare diseases.

Customers and Partnerships

• Biotech — Certara provides tailored guidance and integrated services to help biotech companies build on early successes, achieve sustainable growth, and attract critical investment.
• Large Pharma — Certara empowers large pharmaceutical organizations to break down silos, align priorities, and optimize decision-making across global teams and complex pipelines.
• CROs — Certara's solutions help contract research organizations maximize efficiency, improve client alignment, and deliver results with speed and precision.

With a resource library of over 1,000 articles, a dedicated Learning Center, and a broad portfolio of software and services aligned to recognized industry standards, Certara serves as a strategic partner for organizations seeking to accelerate drug development, improve regulatory outcomes, and ultimately bring safer, more effective medicines to patients worldwide.