Overview
Certara is a global leader in biosimulation and model-informed drug development (MIDD) services for pharmaceutical companies. The company provides consulting and technology solutions across non-clinical, clinical, and commercial manufacturing phases, with specialized expertise in oncology drug development, regulatory strategy, and market access optimization. Certara supports large pharma from early discovery through post-marketing stages, helping optimize decision-making and accelerate drug approvals.
Frequently asked questions
- What core services does Certara offer to pharmaceutical R&D teams?
- Certara provides model-informed drug development (MIDD), quantitative systems pharmacology (QSP), biosimulation, regulatory consulting, and market access solutions. Services span early molecular design, clinical dose optimization, regulatory submissions, and commercial strategy across discovery, development, and post-marketing phases.
- What is Certara's expertise in oncology drug development?
- Certara offers specialized MIDD oncology capabilities to help large pharma optimize study decisions, prioritize effectively, and improve clinical outcomes. The company uses biosimulation and modeling to accelerate oncology drug development timelines and support regulatory strategy.
- How does Certara support regulatory approval and market access?
- Certara provides pharmaceutical regulatory consulting with data-driven strategies for global submissions, streamlining complex regulations to speed approvals. The company also offers market access solutions that demonstrate drug value, optimize pricing for payer expectations, and maximize patient access while supporting profitability.