Contact Investors Careers Support Search English Model-informed Drug Development Data and Informatics Regulatory and Access Resources Company Simcyp™ Simulator V21 Expands Capabilities to Align with Recent Regulatory Guidances Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drugs Learn More Since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA Free 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 and tech-enabled services. In 2020, more than 1,650 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and tech-enabled services. As your trusted partner, 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 and/or Simcyp™ PBPK Simulator software platforms, including the US FDA and EMA. We are proud to say that our customers, who use our biosimulation software and services, have received over 90% of all new drug approvals by the FDA since 2014. How we help our clients Integrated Drug Development We tailor clinical pharmacology, pharmacometrics, pharmacokinetic and pharmacodynamic (PK/PD) analysis, and regulatory strategies to get to proof of concept faster, choose the right dose, and reduce clinical trial size or avoid certain trials altogether. Learn more Regulatory Science We accelerate regulatory submissions and approvals with customized regulatory submission strategy, communications and operations, powered by our proprietary artificial intelligence technology and supported by the GlobalSubmit™ eCTD platform. Learn more Biosimulation and Informatics Software We provide software spanning the entire drug development lifecycle, from D360™ scientific informatics to mechanistic modeling with the Simcyp™ PBPK Simulator and Quantitative Systems Pharmacology and the Phoenix™ PK/PD platform. Learn more Evidence and Access We optimize value with decision analytics and modeling, value and access consulting, and real world data solutions, powered by our HOPE™ Bayesian modeling engine and communicated via our BaseCase™ platform. Learn more Latest from Certara ANNOUNCEMENT Seven Scientists at Certara Featured in List of Top 2% Scientists Worldwide PRESS RELEASE: Certara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 Award ARTICLE: PHARMACEUTICAL COMMERCE Pharma & Big Data: New Heights Beckon CASE STUDY Organizing Complex Virology Datasets into FDA-Ready Format using SAS Programming PRESS RELEASE Pinnacle 21 Awarded FDA Contract for 5 Years for Software and Services ARTICLE: DRUG DISCOVERY WORLD ON DEMAND WEBINAR FDA’s Digital Transformation: The Future of Technology and How to Prepare CASE STUDY: CAR-T Using Modeling to Demonstrate the Kinetics of Liso-Cel Transgene WHITE PAPER Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling & Simulation ARTICLE: BIOIT WORLD New Discovery Data Architecture Needed to Support New Modalities 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. Learn 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 How can we help you? Contact us today to discuss how we can accelerate your program. Services Anonymization and Redaction Cell and Gene Therapy Clinical Pharmacology Clinical Pharmacology Study Stewardship Complex Biologics Decision Analytics and Modeling Document Quality and Management Drug Development and Regulatory Strategy eCTD Authoring Templates French SNDS Data Access and Analysis See more Software PHOENIX™ PK/PD PLATFORM v 8.3 Phoenix WinNonlin Simcyp PBPK Simulator Quantitative Systems Pharmacology D360 Scientific Informatics Platform Integral Data Repository BaseCase Value Communication Software CODEx & Clinical Trial Outcomes Databases GlobalSubmit eCTD Submissions Software Phoenix WinNonlin Validation Suite See more Resources Articles Blogs Best of Blogs 2020 Case Studies Certara in the Press Certara University Certification Program Conferences Knowledge Base Podcasts See more Company Careers Certara Code of Conduct Contact Certara Leadership Legal Locations News Our Story Partners Privacy Center See more English Privacy Center Legal By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies Settings Accept All Cookies