The right technology can transform drug development, surfacing and connecting insights from discovery through market access. Trusted by regulatory agencies worldwide, our platforms for lead optimization, biosimulation, PK/PD modeling, clinical data validation and more accelerate every stage of development with the power of prediction. Our vision? Insights that flow through every phase to break siloes and drive collaboration.
Biosimulation, validation, standardization, and value at its best
Certara’s comprehensive software solutions ensure that you get maximum value from your drug development efforts.
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Certara software solutions
The industry's most trusted PK/PD platform for non-compartmental analysis (NCA), population PK (popPK), IVIVC, and more.
Our PBPK modeling software is the most widely adopted platform for PBPK modeling in drug development. Find out more about
Increase the speed and quality of your clinical trial submission data with the Pinnacle 21® Clinical Data Management & Automation
Enhance drug discovery workflows with D360™, the premier informatics platform for managing and analyzing complex data.
Certara IQ is an AI-enabled QSP modeling software that scales quantitative systems pharmacology, offering validated models, workflows, and regulatory-ready insights.
Use Certara's AI platform for Life Sciences to solve data silo problems while improving analytics capabilities that boost productivity.
Publish, validate, and review your eCTD submissions with GlobalSubmit eCTD Software, eliminating risk and expediting regulatory acceptances.
Accelerate the creation of regulatory documents with AI-generated content, freeing up writers for key analysis, messaging, and refinement.
Our Value Communication Software empowers market access pharma teams with interactive tools to showcase product value.
A validated, web-based application to provide advanced viewing, data summarization, and visualization capabilities for study non-clinical data produced in SEND
Simplify clinical trial analytics with unstructured data analysis for better trial design and outcomes.
The industry’s largest scientist-curated database to assess drug interactions and safety
Market Access Radar delivers up-to-date pricing and reimbursement data from global sources, helping you navigate market access challenges with confidence.
The industry’s gold standard for PK/PD analysis, raised to the power of the cloud. Move faster from data ingestion to
Simcyp PBPK provides physiologically based pharmacokinetic modeling to predict drug behavior in diverse populations.
Build studies with greater speed and quality
A complete cheminformatics workbench for molecule design, property calculation, search, data management, and more.
Create health authority compliant eCTD submissions quickly and accurately.
Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
Included with Phoenix® Hosted, Certara’s Integral equips PK scientists with an API-enabled data repository supporting both GXP and non-GxP studies.
Innovative PBPK software that supports screening, first-in-human dose prediction, early DDI and formulation decisions.
Pinnacle 21 Enterprise non-CRF data management software provides automated validation & in-app collaboration, enabling accurate deliverables, faster.
Enhance your drug discovery process with the combined power of D360 and Design Hub.
Certara’s QSP modeling platform for immuno-oncology predicts optimal combinations, dose regimens, and biomarkers in virtual patients, for IO therapies.
Powerful but simple review of all your submissions across programs and stakeholders.
A trusted solution for pharmacokinetic, pharmacodynamic, and non-compartmental analysis.
Simcyp Biopharmaceutics software is an advanced PBPK platform for biopharmaceutics, formulation, and CMC experts.
Pinnacle 21® Enterprise CRF Creator allows you to design and build full studies for leading EDC systems, in one central
Certara’s D360 platform partners with renowned organizations to provide a comprehensive suite of informatics solutions tailored for discovery research. By
Integrated platform for smaller pharmaceutical teams to seamlessly access, integrate, and analyze data
Certara’s Inflammatory Bowel Disease (IBD) QSP Platform Model is based on a mechanistic multi-state mathematical model to predict disease activity
The modern PK/PD modeling software for today’s scientists, Phoenix® NLME streamlines pharmacokinetic and pharmacodynamic modeling.
Predict toxicological outcomes faster with Certara ToxStudio®—an in silico toxicology platform streamlining workflows, reducing animal testing, and enabling regulatory insights.
Do clinical data validations for SDTM, ADaM & SEND datasets and easily run define validations in one central platform.
Certara’s Immunogenicity (IG) Simulator is a QSP immunogenicity prediction tool that predicts immunogenicity incidence and its impact on PK/PD.
Streamline in vitro data analysis of whole cell systems and dissolution studies to feed into PBPK modeling
Managing clinical data issues across decentralized teams can be a daunting and time-consuming task. Pinnacle 21 Enterprise (P21E) clinical data
Certara’s QSP models for neuroscience drug discovery offer mechanism-based models for Alzheimer’s, Parkinson’s, psychotic disorders, and more.
Travel a faster, more reliable path to biowaivers with our enhanced tools for in vitro-in vivo correlation.
PBPK/PD modeling platform to streamline preclinical and veterinary drug research for rats, dogs, monkeys, and mice.
Define.xml is a critical component of regulatory submissions for SDTM, SEND, and ADaM datasets. However, creating these files manually is
The Gene Therapy Model Pack includes 8 validated QSP models covering gene therapies like LNP-encapsulated mRNA and siRNA.
Reduce the time & complexity to prepare and analyze pharmacokinetic (PK) datasets.
Certara’s Simcyp Biologics platform enables scientists to model and predict the pharmacokinetics and pharmacodynamics of biologics, enhancing drug development and
Regulatory agencies rely on clear and detailed documentation to navigate clinical data submissions. The Study Data Reviewer’s Guide (SDRG) provides
The ADC Model Pack includes multiple validated QSP models for monospecific and bispecific antibody-drug conjugates (ADC) with and without avidity.
RsNLME is a collection of R packages & RShiny apps that allow scientists to run models using the Certara NLME
Advanced platform that uses AI-driven modeling and simulation to assess the pro-arrhythmic risk of drugs, helping to ensure cardiovascular safety
The Cell Engager Model Pack includes validated QSP models for solid tumors, in vitro experiments, & solid tumors with 2
Prevent rejections in the late stages of drug development & maximize chances of success with Certara's Trial Simulator.
Simcyp® Pediatric Pharmacokinetics: Advanced PBPK Modeling for Pediatric Drug Development.
The Biotherapeutic Model Pack is a library of monospecific and bispecific, single- and multi-compartment validated QSP models for biotherapeutics.
Certara’s Vaccine Simulator uses Quantitative Systems Pharmacology (QSP) to determine optimal vaccine dosing strategies for patients.
The Protein Degrader Model Pack includes validated QSP models for protein degrader pharmacologies like PROTACs and Molecular Glue Degraders.
The Avidity Model Pack includes validated QSP models covering soluble and membrane ligand pharmacologies, with avidity.
Predict and analyze off-target risks in drug development for safer outcomes.
Software resources
View allTransforming drug development with integrated AI
Certara’s software solutions support the entire drug development lifecycle—from discovery to market access—empowering strategy, streamlining processes and enhancing decision-making. By integrating advanced AI capabilities, Certara envisions a future where its tools seamlessly communicate, breaking down silos and fostering knowledge sharing across all phases. This interconnected approach will create higher efficiency, greater insights, and a unified strategy for regulatory and commercial success.
Certara enables visionary leaders to achieve unprecedented collaboration and innovation across their development programs.
Find the platform to transform your drug
We know – we have a formidable and comprehensive range of software products. Ask us to help navigate you to the right product. Whether you know your product of interest or not, send an inquiry and we’ll do our utmost to connect you to the platform that serves you best.
Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2025.
Seamlessly integrate the right expert at any development stage.
Reduce timelines, costs, and risks with our proven, trusted solutions.
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