# Certara: The global leader in biosimulation with leading software and services spanning modeling and simulation, regulatory science, and market access > Certara's transformative drug development solutions include data\-driven modelling, AI and predictive simulation\. Accelerate your development process for good Generated by Yoast SEO v28.1, this is an llms.txt file, meant for consumption by LLMs. ## Pages - [Our Story](https://www.certara.com/our-story/) - [Contact](https://www.certara.com/company/contact/) - [Legal Notice](https://www.certara.com/legal/) - [Privacy Center](https://www.certara.com/legal/privacy-center/) - [Regulatory Adoption](https://www.certara.com/company/regulatory-adoption/) - [Solutions](https://www.certara.com/solutions/) - [Strategic Leadership](https://www.certara.com/solutions/strategic-leadership/) - [Non\-Animal Navigator](https://www.certara.com/solutions/non-animal-navigator/): Expert strategy and AI\-enabled biosimulation to reduce, refine, or replace animal studies - [NAM Strategies](https://www.certara.com/solutions/non-animal-navigator/nam-strategies/): Tailored NAM strategies to reduce animal use, support global regulatory alignment, and accelerate your drug development program with expert guidance\. - [Software](https://www.certara.com/software/) - [Phoenix® PK/PD Platform](https://www.certara.com/software/phoenix-pkpd/): The industry's most trusted PK/PD platform for non\-compartmental analysis \(NCA\), population PK \(popPK\), IVIVC, and more\. - [Phoenix WinNonlin](https://www.certara.com/software/phoenix-winnonlin/): A trusted solution for pharmacokinetic, pharmacodynamic, and non\-compartmental analysis\. - [Phoenix Cloud](https://www.certara.com/software/phoenix-pkpd/phoenix-cloud/): The industry’s gold standard for PK/PD analysis, raised to the power of the cloud\. Move faster from data ingestion to TFL and report generation\. - [Phoenix® NLME](https://www.certara.com/software/phoenix-nlme/): The modern PK/PD modeling software for today’s scientists, Phoenix® NLME streamlines pharmacokinetic and pharmacodynamic modeling\. - [R speaks NLME \(RsNLME\)](https://www.certara.com/software/r-speaks-nlme-rsnlme/): RsNLME is a collection of R packages \& RShiny apps that allow scientists to run models using the Certara NLME engine directly from the R command line\. - [Integral Data Repository](https://www.certara.com/integral-data-repository/): Included with Phoenix® Hosted, Certara’s Integral equips PK scientists with an API\-enabled data repository supporting both GXP and non\-GxP studies\. - [Pirana Modeling Workbench](https://www.certara.com/software/pirana-modeling-workbench/): Pirana® provides a collaborative environment for managing and executing pharmacometric workflows, fully compatible with RsNLME\. - [Trial Simulator](https://www.certara.com/software/trial-simulator/): Prevent rejections in the late stages of drug development \& maximize chances of success with Certara's Trial Simulator\. - [PK Submit](https://www.certara.com/software/pk-submit/): Reduce the time \& complexity to prepare and analyze pharmacokinetic \(PK\) datasets\. - [Pinnacle 21 Clinical Data Management \& Automation Suite](https://www.certara.com/pinnacle-21-enterprise-software/): Increase the speed and quality of your clinical trial submission data with the Pinnacle 21® Clinical Data Management \& Automation Suite\. - [Pinnacle 21 \- Clinical Metadata Repository](https://www.certara.com/pinnacle-21-enterprise-software/clinical-metadata-repository/): Build studies with greater speed and quality - [CRF design \& EDC build in Pinnacle 21](https://www.certara.com/pinnacle-21-enterprise-software/crf-design-edc-build/) - [Define\-XML](https://www.certara.com/pinnacle-21-enterprise-software/define-xml/) - [Validation](https://www.certara.com/pinnacle-21-enterprise-software/validation/): Do clinical data validations for SDTM, ADaM \& SEND datasets and easily run define validations in one central platform\. - [Issue Management](https://www.certara.com/pinnacle-21-enterprise-software/issue-management/) - [Study Data Reviewer’s Guide](https://www.certara.com/pinnacle-21-enterprise-software/study-data-reviewers-guide/) - [External Vendor Data Exchange](https://www.certara.com/pinnacle-21-enterprise-software/external-vendor-data-exchange/): Pinnacle 21 Enterprise non\-CRF data management software provides automated validation \& in\-app collaboration, enabling accurate deliverables, faster\. - [SDTM Specification Management](https://www.certara.com/pinnacle-21-enterprise-software/sdtm-specification-management/): Improve speed, quality and compliance when creating SDTM mapping specifications in Pinnacle 21’s SDTM data mapping software\. - [Simcyp](https://www.certara.com/simcyp/): Our PBPK modeling software is the most widely adopted platform for PBPK modeling in drug development\. Find out more about our Simcyp™ Platform here\. - [Simcyp PBPK](https://www.certara.com/software/simcyp-pbpk/): Simcyp PBPK provides physiologically based pharmacokinetic modeling to predict drug behavior in diverse populations\. - [Simcyp Discovery](https://www.certara.com/simcyp/discovery/): Innovative PBPK software that supports screening, first\-in\-human dose prediction, early DDI and formulation decisions\. - [Simcyp Biopharmaceutics](https://www.certara.com/software/simcyp-biopharmaceutics/): Simcyp Biopharmaceutics software is an advanced PBPK platform for biopharmaceutics, formulation, and CMC experts\. - [Simcyp PBPK](https://www.certara.com/services/simcyp-pbpk/): Global consulting team applying PBPK modeling to all stages in drug development\. - [Simcyp In Vitro Data Analysis Toolkit \(SIVA\)](https://www.certara.com/software/simcyp-in-vitro-data-analysis-toolkit-siva/): Streamline in vitro data analysis of whole cell systems and dissolution studies to feed into PBPK modeling - [Secondary Intelligence](https://www.certara.com/toxstudio/secondary-intelligence/): Predict and analyze off\-target risks in drug development for safer outcomes\. - [D360 Scientific Informatics Platform](https://www.certara.com/d360-scientific-informatics-platform/): Enhance drug discovery workflows with D360™, the premier informatics platform for managing and analyzing complex data\. - [D360 Express](https://www.certara.com/d360-scientific-informatics-platform/d360-express/): Integrated platform for smaller pharmaceutical teams to seamlessly access, integrate, and analyze data - [Chemaxon](https://chemaxon.com/): A complete cheminformatics workbench for molecule design, property calculation, search, data management, and more\. - [Certara\.AI](https://www.certara.com/certara-ai/): Use Certara's AI platform for Life Sciences to solve data silo problems while improving analytics capabilities that boost productivity\. - [CoAuthor](https://www.certara.com/coauthor/): Accelerate the creation of regulatory documents with AI\-generated content, freeing up writers for key analysis, messaging, and refinement\. - [CODEX: A\.I\.\-Powered Analytics](https://www.certara.com/codex-clinical-trial-outcomes-databases/): Simplify clinical trial analytics with unstructured data analysis for better trial design and outcomes\. - [BaseCase Value Communication Platform](https://www.certara.com/basecase/): Our Value Communication Software empowers market access pharma teams with interactive tools to showcase product value\. - [GlobalSubmit eCTD Submission Software](https://www.certara.com/globalsubmit-ectd-submission-software/): Publish, validate, and review your eCTD submissions with GlobalSubmit eCTD Software, eliminating risk and expediting regulatory acceptances\. - [GlobalSubmit™ REVIEW](https://www.certara.com/globalsubmit-ectd-submission-software/review/): Powerful but simple review of all your submissions across programs and stakeholders\. - [GlobalSubmit™ PUBLISH](https://www.certara.com/globalsubmit-ectd-submission-software/publish/): Create health authority compliant eCTD submissions quickly and accurately\. - [SEND Explorer Software](https://www.certara.com/send-explorer-software/): A validated, web\-based application to provide advanced viewing, data summarization, and visualization capabilities for study non\-clinical data produced in SEND format\. - [Market Access Radar](https://www.certara.com/mar-market-access-radar/): Market Access Radar delivers up\-to\-date pricing and reimbursement data from global sources, helping you navigate market access challenges with confidence\. - [Drug Interaction Database \(DIDB®\)](https://www.certara.com/drug-interaction-database-didb/): The industry’s largest scientist\-curated database to assess drug interactions and safety - [ToxStudio](https://www.certara.com/toxstudio/): Predict toxicological outcomes faster with Certara ToxStudio®—an in silico toxicology platform streamlining workflows, reducing animal testing, and enabling regulatory insights\. - [Quantitative Systems Pharmacology Software](https://www.certara.com/software/quantitative-systems-pharmacology/): Certara IQ is an AI\-enabled QSP modeling software that scales quantitative systems pharmacology, offering validated models, workflows, and regulatory\-ready insights\. - [Modeling and Simulation Services](https://www.certara.com/services/modeling-and-simulation-services/): Accelerate drug development with customized biosimulation to predict efficacy, safety, and optimal dosing strategies\. - [Pharmacometrics Services](https://www.certara.com/services/pharmacometrics/): Our experienced pharmacometrics services team helps quantify drug\-patient interactions, optimize development \& regulatory choices\. - [Quantitative Systems Pharmacology](https://www.certara.com/services/quantitative-systems-pharmacology/): Choose Certara's Quantitative Systems Pharmacology \(QSP\) consulting services to enhance drug development with computational modeling and experimental data\. - [Biometrics \& Data Sciences](https://www.certara.com/services/biometrics-data-sciences/): Tailored biometrics capabilities that cover the full drug development continuum \(pre\-clinical through NDA/BLA\)\. - [PK/PD Data Programming \& Support](https://www.certara.com/pk-pd-data-programming-support/): Bridge the gap between your analysis plans and modeling requirements\. - [Biostatistics and Statistical Programming](https://www.certara.com/services/biometrics-data-sciences/biostatistics-and-statistical-programming/): Advanced biostatistics consulting and CDISC\-compliant SDTM \& ADaM datasets - [Drug Development Services](https://www.certara.com/services/drug-development-services/): Tap into knowledge of our experts who have thousands of years of combined experience across drug development\. - [Early Development](https://www.certara.com/services/early-development/): Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1\. - [Bio Venture Catalyst](https://www.certara.com/services/bio-venture-catalyst/): Discover expert insights on biotech funding, startup investment strategies, and securing capital for biotech ventures\. Empower your growth with proven funding solutions\. - [Due Diligence and Asset Evaluation](https://www.certara.com/services/bio-venture-catalyst/): Partner with Certara for data\-driven due diligence, asset evaluation, and risk mitigation to support smarter biotech investments and portfolio growth\. - [Clinical Pharmacology](https://www.certara.com/services/clinical-pharmacology/): Analysis and strategies with the main objective of ensuring a successful drug development program\. - [Regulatory Affairs Consulting](https://www.certara.com/services/early-development/regulatory-affairs-consulting/): Strategic guidance and end\-to\-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through market approval\. - [Regulatory Science](https://www.certara.com/regulatory-science/): Navigate regulatory complexities with expert support for submissions, compliance, and strategies to expedite approvals\. - [Evidence, Value \& Access](https://www.certara.com/evidence-access/): Our Pharmaceutical Market Access team optimizes product value, positioning, and evidence synthesis through all stages of reimbursement including HEOR, RWE, etc - [Health Economics Outcomes Research](https://www.certara.com/evidence-access/health-economics-outcomes-research/): With 25\+ years of HEOR consulting expertise, we offer HTA health economic analyses, clinical trial analytics for HTA applications, epidemiology models, and more\. - [Real World Data Solutions](https://www.certara.com/evidence-access/real-world-evidence/): Discover Certara's comprehensive Real\-World Evidence Services\. We provide innovative RWE solutions for pharma, empowering regulatory, market access, and clinical strategies\. - [Value and Strategy](https://www.certara.com/evidence-access/value-strategy/): Explore Certara's Value and Access services, a combination of proven payer strategies and scientific excellence to optimize market access\. - [Market Access and Pricing](https://www.certara.com/evidence-access/market-access-and-pricing/): Certara’s Market Access \& Commercial solutions provide strategic insights and tools to optimize pricing, reimbursement, and market entry strategies\. - [Therapeutic Specialties](https://www.certara.com/services/therapeutic-areas/) - [Services](https://www.certara.com/services/) - [Customers](https://www.certara.com/customers/): Certara partners with top global pharmaceutical companies, emerging biotechs, and regulatory agencies to transform drug development for good\. ## Posts - [Phoenix Roadshow 2026 \- Tokyo​](https://www.certara.com/live-events/phoenix-roadshow-tokyo-2026/): \[event\_date\_range\] - [Certara Biotech Forum: Workshop on Developing Investor\-Ready Strategies](https://www.certara.com/live-events/certara-biotech-forum-workshop-on-developing-investor-ready-strategies-boston/): \[event\_date\_range\] – \[acf field="event\_location"\] - [Introducing Certara NEXUS: The AI OS for Drug Discovery, Development, and Submission](https://www.certara.com/webinar/introducing-certara-nexus-the-ai-os-for-drug-discovery-development-and-submission/): \[event\_date\_range\] - [Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD](https://www.certara.com/on-demand-webinar/earning-regulatory-trust-practical-strategies-to-increase-model-acceptance/): Discover practical strategies to increase regulatory trust and acceptance of MIDD models, including PBPK and QSP\. Learn how to demonstrate model credibility, avoid common red flags, and align with regulatory expectations\. - [Unlock the Power of SEND Data: From FDA Compliance to Global Regulatory Readiness for Preclinical Data \[Korean Webinar with Biotoxtech\]](https://www.certara.com/webinar/unlock-the-power-of-send-data-from-fda-compliance-to-global-regulatory-readiness-for-preclinical-data-korean-webinar/): \[event\_date\_range\] ## Teams - [Adrian Stevens](https://www.certara.com/teams/adrian-stevens/) - [James Blauvelt](https://www.certara.com/teams/james-blauvelt/) - [Maia Green, PhD](https://www.certara.com/teams/maia-green-phd/) - [Douglas W\. Chung, BS, MS](https://www.certara.com/teams/douglas-w-chung-bs-ms/) - [Hugo Geerts, PhD](https://www.certara.com/teams/hugo-geerts-phd/) ## Popup Themes - [Default Theme](https://www.certara.com/?post_type=popup_theme&p=74345) - [Light Box](https://www.certara.com/?post_type=popup_theme&p=74346) - [Enterprise Blue](https://www.certara.com/?post_type=popup_theme&p=74347) - [Hello Box](https://www.certara.com/?post_type=popup_theme&p=74348) - [Cutting Edge](https://www.certara.com/?post_type=popup_theme&p=74349) ## Optional - [Sitemap index](https://www.certara.com/sitemap_index.xml)