"I love Certara | Accelerating Medicines with Biosimulation and Tech-enabled Services"

2022-05-09 20:10:41

ContactInvestorsCareersSupport Model-informed Drug DevelopmentTech-driven ServicesClinical PharmacologyEarly Development IND Enabling ServicesDrug Development and Regulatory StrategyModel-based Meta AnalysisPharmacometricsQuantitative Systems PharmacologyQuantitative Systems Toxicology and SafetySimcyp Physiologically-based Pharmacokinetic ModelingVirtual BioequivalencePhoenix™ PK/PD SoftwarePhoenix WinNonlinPhoenix PKPD PlatformPhoenix NLMER speaks NLME (RsNLME)Phoenix IVIVC ToolkitPK SubmitPirana Modeling WorkbenchTrial SimulatorSimcyp Mechanistic SoftwareSimcyp PBPK SimulatorSimcyp BiologicsSimcyp Pediatrics SimulatorThe Simcyp ConsortiumQuantitative Systems PharmacologyQuantitative Systems Toxicology and SafetyFeatured ProductCertara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 AwardData and InformaticsPinnacle 21 Regulatory/CDISC Compliance SoftwareD360 Scientific Informatics PlatformIntegral Data RepositoryCODEx and Clinical Trial Outcomes DatabasesSEND Explorer Featured Product Pinnacle 21 Enterprise Software Regulatory and AccessRegulatory ServicesRegulatory WritingScientific and Medical Communications and PublicationsSafety and PharmacovigilanceRegulatory Consulting and Regulatory AffairsSubmission LeadershipRegulatory OperationsTransparency and DisclosureEvidence and Access TechnologyBaseCase Value Communication SoftwareMarket Access RadarRegulatory TechnologyGlobalSubmit eCTD Submissions SoftwarePinnacle 21 Regulatory/CDISC Compliance SoftwareSynchrogenix WriterEvidence and Access ServicesReal World Data SolutionsDecision Analytics and ModelingHealth Economics Outcomes Research (HEOR)PricingUS and EU Payer EngagementValue and StrategyFeaturedMoving Advanced Therapies to the Next Level: Tackling the Key Challenges When Transitioning from Nonclinical to Clinical Development ResourcesResourcesArticlesOn-Demand WebinarsBlogsPodcastsBrochuresPostersCase StudiesPublicationsConferencesSuccess StoriesKnowledge BaseWebinarsNewsWhite PapersSupportTrainingCertara UniversityProfessional CertificationSimcyp WorkshopsMost PopularSimcyp: 20 Years of Innovation100 Articles That Will Help You Understand PBPK Modeling & SimulationBiohaven achieves FDA approval with Nurtec™CompanyCareersContactOur StoryResponsibilityRegulatory AdoptionLeadershipNewsLatest NewsCertara Reports First Quarter 2022 Financial ResultsCertara to Participate in Upcoming Investor Conferences Mobile Toggle Mobile Toggle Model-informed Drug DevelopmentTech-driven ServicesClinical PharmacologyEarly Development IND Enabling ServicesDrug Development and Regulatory StrategyModel-based Meta AnalysisPharmacometricsQuantitative Systems PharmacologyQuantitative Systems Toxicology and SafetySimcyp Physiologically-based Pharmacokinetic ModelingVirtual BioequivalencePhoenix™ PK/PD SoftwarePhoenix WinNonlinPhoenix PKPD PlatformPhoenix NLMER speaks NLME (RsNLME)Phoenix IVIVC ToolkitPK SubmitPirana Modeling WorkbenchTrial SimulatorSimcyp Mechanistic SoftwareSimcyp PBPK SimulatorSimcyp BiologicsSimcyp Pediatrics SimulatorThe Simcyp ConsortiumQuantitative Systems PharmacologyQuantitative Systems Toxicology and SafetyFeatured ProductCertara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 AwardData and InformaticsPinnacle 21 Regulatory/CDISC Compliance SoftwareD360 Scientific Informatics PlatformIntegral Data RepositoryCODEx and Clinical Trial Outcomes DatabasesSEND Explorer Featured Product Pinnacle 21 Enterprise Software Regulatory and AccessRegulatory ServicesRegulatory WritingScientific and Medical Communications and PublicationsSafety and PharmacovigilanceRegulatory Consulting and Regulatory AffairsSubmission LeadershipRegulatory OperationsTransparency and DisclosureEvidence and Access TechnologyBaseCase Value Communication SoftwareMarket Access RadarRegulatory TechnologyGlobalSubmit eCTD Submissions SoftwarePinnacle 21 Regulatory/CDISC Compliance SoftwareSynchrogenix WriterEvidence and Access ServicesReal World Data SolutionsDecision Analytics and ModelingHealth Economics Outcomes Research (HEOR)PricingUS and EU Payer EngagementValue and StrategyFeaturedMoving Advanced Therapies to the Next Level: Tackling the Key Challenges When Transitioning from Nonclinical to Clinical Development ResourcesResourcesArticlesOn-Demand WebinarsBlogsPodcastsBrochuresPostersCase StudiesPublicationsConferencesSuccess StoriesKnowledge BaseWebinarsNewsWhite PapersSupportTrainingCertara UniversityProfessional CertificationSimcyp WorkshopsMost PopularSimcyp: 20 Years of Innovation100 Articles That Will Help You Understand PBPK Modeling & SimulationBiohaven achieves FDA approval with Nurtec™CompanyCareersContactOur StoryResponsibilityRegulatory AdoptionLeadershipNewsLatest NewsCertara Reports First Quarter 2022 Financial ResultsCertara to Participate in Upcoming Investor Conferences ContactInvestorsCareersSupport With Project Optimus, Success Favors the PreparedArticle: Applied Clinical Trials, May 2, 2022Oncology drug developers must start asking questions in preparation of FDARead ArticleAccelerating medicines with biosimulation, technology and servicesFree Consultation . Certara's Better Drug Discovery and Development Process The drug discovery and development process is long and expensive with more failures than successes. At Certara, we anticipate and address your critical drug discovery and development risks and decisions using biosimulation, technology and services. In 2021, more than 2,000 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and technology-driven services. We support confident decision-making throughout the entire biopharma R&D process to reduce cycle times, lower costs and improve outcomes for patients. Additionally, 17 global regulatory agencies have adopted our Phoenix™ PK/PD, Pinnacle 21 and/or Simcyp™ PBPK Simulator software, including the US FDA, Japan's PMDA and China's NMPA.We are proud to say that our customers, who use our biosimulation software and services, have received 90% of all new drug approvals by the FDA since 2014. How we help our clients Simcyp PBPK SimulatorPredict drug performance with Simcyp PBPK Simulator.- Determine first-in-human dosing - Optimize clinical study design- Evaluate new drug formulations- Predict drug-drug interactions Learn more Phoenix WinNonlinAccomplish more with Phoenix WinNonlin, the industry-leading software for:- PK/PD analysis- Noncompartmental analysis (NCA)- Toxicokinetics. Learn more Integrated Drug DevelopmentIncrease probability of success with model-informed drug development.- Drug development & regulatory strategy- Nonclinical development- Clinical pharmacology and pharmacometricsLearn more Regulatory and AccessAssure regulatory and commercial success, powered by great people and technology. - Regulatory writing- Regulatory operations- Real-world data solutions- Market accessLearn more Latest from Certara Get Support for Project OptimusNEW! Optimus Fitness & Gap Analysis SolutionsGet Support for Project OptimusPinnacle 21 - New ReleaseCheck out new capabilitiesPinnacle 21 - New ReleaseSimcyp SimulatorVideo DemoSimcyp SimulatorAssessing Drug SafetyBlogAssessing Drug SafetyCertara's First ESG ReportInnovating to Improve LivesCertara's First ESG ReportSimcyp Wins WCOP 2022 Poster Visualization AwardPosterSimcyp Wins WCOP 2022 Poster Visualization AwardPBPK Modeling of Antibody-Drug Conjugates – Concept and ApplicationOn Demand WebinarPBPK Modeling of Antibody-Drug Conjugates – Concept and Application Certara Events and WebinarsUpcomingPast Events09 May, Monday - 11 May, WednesdayISMPP 2022Conference09 May, Monday - 12 May, ThursdayAAPS NBC 2022Conference11 May, Wednesday - 11 May, WednesdayTOPRA Regulatory Careers Live – 2022Conference12 May, ThursdayLearn why Phoenix is the industry gold standard for PK/PD analysisWebinar15 May, Sunday - 18 May, WednesdayISPOR 2022Conference16 May, Monday - 17 May, TuesdayReuters Pharma USAConference19 May, ThursdaySmarter Clinical Document Automation for Transparency and Disclosure RequirementsWebinar19 May, Thursday - 22 May, SundayDIA China 2022Conference22 May, Sunday - 25 May, WednesdayPharmaSUG 2022: May 22-25 in Austin, TXConference24 May, TuesdayCertara University’s Centers of Excellence Express Webinar Series 2022Webinar24 May, Tuesday - 25 May, WednesdayReuters Customer Engagement EuropeConference24 May, TuesdayA New Tool to Gain Market Access Intelligence in MinutesWebinar13 Jun, Monday - 16 Jun, ThursdayBIO International Convention 2022Conference15 Jun, WednesdayApproaches to Address the Regulatory Requirements for System Qualification of the Simcyp SimulatorWebinar19 Jun, Sunday - 23 Jun, ThursdayDIA Global 2022Conference28 Jun, Tuesday - 01 Jul, FridayPAGE 2022Conference11 Jul, Monday - 13 Jul, WednesdayWorld Orphan Drug Congress 2022Conference06 May, Friday - 05 May, ThursdayAMWA Carolinas Spring ConferenceConference03 May, Tuesday - 07 May, SaturdayEMWA – European Medical Writers AssociationConference27 Apr, WednesdayLearn how Certara’s Integral streamlines PK/PD workflows & ensures compliance with regulatory requirementsOn-Demand Webinar01 Jan, Thursday - 01 Jan, ThursdayClinical Data Disclosure, Transparency and Plain Language Summaries 2022Conference01 Jan, Thursday - 01 Jan, ThursdayQuantitative Systems Pharmacology Conference (QSPC2022)Conference#calendar .nav{background: #0093bc;}#calendar .nav .btn-link{color: #fff}#calendar .hidden-event-con{display:none;}#calendar .calendar-title a {color:#fff;}#calendar .event-title{display:block;margin-bottom: 10px;} Join our team Our people are our success. Teamwork and our individual differences, experiences, and capabilities are essential not only to delivering on our customer commitments but also to fostering our collaborative culture and world-class reputation. - Collaborate with leading experts - Work on a wide range of drug programs - Enjoy flexibility, competitive benefits, and a culture of passion and funLearn more Success isn’t just measured financially at Certara. It is measured in terms of the submissions we have authored, the speed with which we publish documents to regulators, and the technology we deploy to accelerate access to new health technologies. It’s such a pleasure to be part of this ensemble of amazing talent at Certara. I learn new things every day from talented colleagues and clients alike. – Justin Edge President, Regulatory and Access Here at Certara I have access to key experts, and there is great sharing of knowledge and collective team spirit. We are surrounded by great leaders who are still doing science and inspiring work. Every day we make a difference by pushing the boundaries of science forward for our clients and eventually the patients. – Eva Gil Berglund, PhD Senior Director, Regulatory Strategy Improving public health through model informed drug development (MIDD) is a passion for me. It’s a truly multidisciplinary endeavor bringing together experts here at Certara and our clients. Success is ensuring the right drug discovery and development decisions are made and new medicines are delivered to patients to improve their lives. – S.Y. Amy Cheung, PhD Senior Director, Quantitative Science Strategy How can we help you? Contact us today to discuss how we can accelerate your program. ServicesAnonymization and RedactionCell and Gene TherapyClinical PharmacologyClinical Pharmacology Study StewardshipComplex BiologicsDecision Analytics and ModelingDocument Quality and ManagementDrug Development and Regulatory StrategyeCTD Authoring TemplatesFrench SNDS Data Access and AnalysisGlobal HealthHealth Economics Outcomes ResearchMarket Access and PricingMedical and Regulatory CommunicationsModel-based Meta AnalysisOligonucleotide – Complex BiologicsPatient NarrativesPediatric PracticePharmacometricsPhoenix Technology ServicesPlain Language SummariesPre Clinical / IND Enabling ServicesQuantitative Systems PharmacologyQuantitative Systems Toxicology and SafetyReal World Data SolutionsRegulatory Affairs and Submission StrategyRegulatory OperationsRegulatory TechnologySafety and PharmacovigilanceSimcyp PBPK ModelingTherapeutic AreasTransparency and DisclosureUS and EU Payer EngagementUS Managed MarketsValue StrategyVirtual BioequivalenceVaccine PracticeSoftwarePHOENIX™ PK/PD PLATFORM v 8.3Phoenix WinNonlinSimcyp PBPK SimulatorQuantitative Systems PharmacologyD360 Scientific Informatics PlatformIntegral Data RepositoryBaseCase Value Communication SoftwareCODEx & Clinical Trial Outcomes DatabasesGlobalSubmit eCTD Submissions SoftwarePhoenix WinNonlin Validation SuitePinnacle 21 Enterprise CDISC SoftwarePirana Modeling WorkbenchSecondary IntelligenceTrial SimulatorR speaks NLME (RsNLME)ResourcesArticlesBlogsBest of Blogs 2020Case StudiesCertara in the PressCertara UniversityCertification ProgramConferencesKnowledge BasePodcastsPublicationsRaj’s Corner: Blog RoundupSimcyp Success StorySimcyp 2021: Tackling the toughest challenges in drug development and regulatory advancementSimcyp WorkshopsSupportVirtual PatientsWebinarsWhite PapersCompanyCareersCertara Code of ConductContact CertaraLeadershipLegalLocationsNewsOur StoryPartnersPrivacy CenterThe Simcyp Consortium LinkedInBlogYoutubeTwitterFacebook Privacy CenterLegal Copyright © 2022 Certara, USA. 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