Company profile

Certara

Drug Discovery & Development

Company profile

About Certara

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

Primary marketDrug Discovery & Development
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • oncology
  • pediatrics
  • rare diseases

Who it serves

  • Biotech
  • CROs
  • Large Pharma
  • Regulatory Agencies

Deployment & integration

Cloud Saas · Other deployment with recorded integration context.

Geographic context

MarketsGlobal - 30+ countries
Company sourceOfficial website

Company milestones

Platform expansion

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

Recorded partners

No partners are currently listed.

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

BaseCase

Tell your interactive, data-driven value story

Platform · Cloud SaaSCompany source

Certara IQ

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

Platform · Cloud SaaSCompany source

Certara.AI

The AI platform designed for life sciences

Platform · Cloud SaaSCompany source

Chemaxon

Enhance scientific discovery with chemical and biological intelligence

Software · Cloud SaaSCompany source

CoAuthor

GenAI, templates and structured content for regulatory writing

Software · Cloud SaaSCompany source

D360

Scientific informatics to access, analyze and visualize molecule and bioactivity

Platform · Cloud SaaSCompany source

GlobalSubmit

Publish, review and transmit eCTD submissions

Software · Cloud SaaSCompany source

Non-Animal Navigator

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

Service · OtherCompany source

Phoenix

PK, PD, and toxicokinetic analysis and modeling

Software · Cloud SaaSCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

Evidence position

Publications, clinical validation, and regulatory records connected to this Company appear here.

Research

Publications & preprints

Conditional activation of IL-12 through a Fibronectin-EDB dependent switch gate.

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

Clinical-trial records

Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

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 Therapy

NCT06005610 · Mentioned · TERMINATED

A Monotherapy in Subjects With Advanced Solid Tumors

NCT04221204 · Mentioned · ACTIVE NOT RECRUITING

Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults

NCT04175106 · Mentioned · COMPLETED

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

NCT03497676 · Mentioned · COMPLETED

Regulatory

Regulatory records

No linked records are currently available.

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

Reduced development risk

Through Model-Informed Drug Development (MIDD) and predictive biosimulation

Accelerated regulatory decisions

Using AI-driven tools and model-informed strategies

Optimized trial design

Through advanced simulation and precision dosing

Streamlined IND submissions

With predictive modeling and data standardization

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

No active leadership profiles are currently listed.

06 · Company updates

Updates from Certara

Recent articles published on Certara's official website.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Drug Discovery & Development

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.

Explore the full market directory or compare this Company with additional active profiles.

View all Companies in this market

10 · Pro research

Coming soon

Expanded Company research is in development.

Health AI Central Pro · Coming Soon

Deeper Company research is coming soon.

Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.

ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

Coming Soon