Innovating to expand boundaries of drug development

As the largest drug development consulting firm in quantitative sciences, Certara continues to gain significant experience and expertise in every therapeutic area, from oncology to rare diseases. In doing so, we have developed in-depth capabilities and knowledge that apply across therapeutic areas, such as complex biologics and pediatrics.

We created practice areas to harness and elevate this expertise to deliver unparalleled support to our partners in pursuit of your goals. The traditional drug development playbook is often not the best path to success in these practice areas. They require out-of-the-box thinking and are the perfect fit for modern, integrated drug development, incorporating not only modeling and simulation but also regulatory science and market access solutions.

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The pace of growth and innovation in biotechnology has been staggering. In our work with thousands of biotechs, we have found that regulatory strategy is as critical as clinical trial design.

From due diligence to clinical pharmacology stewardship and virtual drug development, we offer an integrated suite of customized solutions designed to reach your goals, smarter and faster.
Complex biologics


What are complex biologics? They include cell-based therapies, antibody drug conjugates, RNA technologies, multivalent antibodies, immuno-oncology, vaccines, and gene therapies.

Certara supports all phases of development with modeling and simulation, translational modeling, quantitative systems pharmacology, clinical pharmacology, and regulatory submission and strategy.


Certara Global Health (CGH) brings together talent, technology, software, and processes to accelerate the development of medicines for those that need them most.

CGH focuses on creating novel and impactful drug development, regulatory science and patient access approaches that deliver effective and affordable therapies to populations in need around the world.
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Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response.

Certara has unique technology to assess drug performance in all ages. Our experience includes quantitative modeling to determine dosing and safety/ efficacy profile and optimization of formulation and drug labels and developing robust PIPs and PSPs.
Our proven approach

Drug development of complex biologics takes not only advanced skills but also in-depth understanding of risks and an early roadmap that is agile and robust.

Certara Pharmacometrics Our Process Arrows LARGE
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