BaseCase
Tell your interactive, data-driven value story
Company profile
Company profile
Certara is a global leader in drug development solutions, serving the pharmaceutical, biotechnology, and contract research organization (CRO) sectors. With over 1,550 employees across more than 30 countries—28% holding PhDs—Certara integrates science, technology, and regulatory expertise to transform drug development from molecule to market. The company's comprehensive portfolio spans software platforms and professional services that address every phase of drug development, from discovery through market access and commercialization. Certara's software solutions include Phoenix for PK/PD analysis, Simcyp for physiologically-based pharmacokinetic (PBPK) modeling, Pinnacle 21 for data standardization and validation, GlobalSubmit for eCTD submissions, BaseCase for market access value stories, and Certara.AI—an AI platform designed specifically for life sciences. The company's CoAuthor platform leverages generative AI for regulatory writing, while D360 provides scientific informatics for molecular analysis. On the services side, Certara offers modeling and simulation, biometrics and data science, drug development support, regulatory strategy, and real-world evidence and market access consulting. The company specializes in Model-Informed Drug Development (MIDD), using predictive biosimulation to reduce development risk and accelerate decision-making. Certara maintains Centers of Excellence addressing complex therapeutic challenges in oncology, pediatrics, rare diseases, and other specialized areas. The company's mission is to transform drug development for good, helping clients optimize trial design, achieve regulatory milestones, demonstrate value to payers, and ultimately bring safer, more effective therapies to patients worldwide.
Company description Certara official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas · Other deployment with recorded integration context.
Company milestones
Launch of Certara.AI platform for life sciences; CoAuthor GenAI platform for regulatory writing; Non-Animal Navigator for regulatory compliance; expansion of therapeutic Centers of Excellence
Partnerships
No partners are currently listed.
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Tell your interactive, data-driven value story
Integrate biological and pharmacological insights to optimize drug efficacy and safety predictions
The AI platform designed for life sciences
Enhance scientific discovery with chemical and biological intelligence
GenAI, templates and structured content for regulatory writing
Scientific informatics to access, analyze and visualize molecule and bioactivity
Publish, review and transmit eCTD submissions
Navigate complex regulatory landscapes with tailored strategies and AI-driven tools
PK, PD, and toxicokinetic analysis and modeling
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
mAbs · Dec 1, 2026
Precision Dosing of Tacrolimus in Liver Transplantation: Integrating Donor-Recipient CYP3A5 Pharmacogenomics and Drug Interactions.CPT: pharmacometrics & systems pharmacology · Sep 1, 2026
A Practical Alternative to Refine the Estimate of fmCYP3A4 and Evaluate Drug-Drug Interaction Potential for Ziftomenib Using PBPK Modeling to Inform Labeling.CPT: pharmacometrics & systems pharmacology · Sep 1, 2026
Exploring Chemically-Induced Oxidative Stress: A Comparative Study of Zebrafish Embryos and Maturated HepG2 Cells.Toxicology · Aug 8, 2026
Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology.CPT: pharmacometrics & systems pharmacology · Aug 1, 2026
The Implementation Imperative in Clinical Pharmacology.Clinical pharmacology and therapeutics · Aug 1, 2026
Clinical validation
NCT07407582 · Mentioned · RECRUITING
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.NCT07176728 · Mentioned · COMPLETED
Estradiol Therapy In Transgender Women to Research Interactions With HIV TherapyNCT06005610 · Mentioned · TERMINATED
A Monotherapy in Subjects With Advanced Solid TumorsNCT04221204 · Mentioned · ACTIVE NOT RECRUITING
Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy AdultsNCT04175106 · Mentioned · COMPLETED
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and AdolescentsNCT03497676 · Mentioned · COMPLETED
Regulatory
No linked records are currently available.
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Through Model-Informed Drug Development (MIDD) and predictive biosimulation
Using AI-driven tools and model-informed strategies
Through advanced simulation and precision dosing
With predictive modeling and data standardization
05 · Leadership
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Recent articles published on Certara's official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Companies using AI, machine learning, or computational biology to discover new drug candidates, identify drug targets, predict drug efficacy, or accelerate pharmaceutical development. Includes both small molecule and biologics development, precision oncology drug discovery, and AI-driven target identification and molecule design.
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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.