Top Sites>CCertara | Drug Development Solutions

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# 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

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## 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/)
- [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
- [Certara Talks \-  Pivotal Trial Mandate](https://www.certara.com/video/certara-talks-pivotal-trial-mandate/): Explore how the FDA’s shift toward one pivotal trial plus supporting evidence could reshape drug development, regulatory strategy, and clinical research\.
- [ADC Dose Optimization: Applying Model\-Informed Strategies in Development](https://www.certara.com/blog/adc-dose-optimization-applying-model-informed-strategies-in-development/): Explore ADC dose optimization using model\-informed strategies to balance efficacy and safety across antibody drug conjugates development\.
- [Top 5 Recommendations for Successful Interactive Value Messaging](https://www.certara.com/blog/top-5-recommendations-for-successful-interactive-value-messaging/): Explore 5 proven tips for effective interactive value messaging in market access \& life sciences communications\. Engage stakeholders \& drive real impact\.
- [Right Dose, Right Regimen: Model\-Informed Strategies for Antibody–Drug Conjugates \(ADCs\)](https://www.certara.com/on-demand-webinar/right-dose-right-regimen-model-informed-strategies-for-antibody-drug-conjugates-adcs/): Watch this on\-demand webinar to learn how model\-informed strategies using PopPK, PBPK, and QSP can optimize dose and regimen decisions for antibody\-drug conjugates \(ADCs\)\.
- [Certara Enters Definitive Agreement for the Sale of its Regulatory and Medical Writing Business to Veristat](https://www.certara.com/pressrelease/certara-enters-definitive-agreement-for-the-sale-of-its-regulatory-and-medical-writing-business-to-veristat/)

## Teams
- [Georgi Kapitanov, PhD](https://www.certara.com/teams/georgi-kapitanov-phd/)
- [Eva Berglund, PhD](https://www.certara.com/teams/eva-berglund-phd/)
- [Andrew Matteson](https://www.certara.com/teams/andrew-matteson/)
- [Dr\. Britta Wagenhuber](https://www.certara.com/teams/dr-britta-wagenhuber/)
- [Mark Bowlby](https://www.certara.com/teams/mark-bowlby/)

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