Certara’s global consulting team has unparalleled experience across all development phases and in practically every therapeutic area.
We have collaborated with sponsors, both large and small, to provide insight into key decisions, including:
- What programs should be advanced in a strategic drug portfolio?
- How can trials be designed to achieve technical and regulatory success?
- What are the optimal dose and regimen?
- How can we minimize regulatory risk and expedite pathways?
- How do we optimize value and expand market access?
With the largest and most diverse, expert team of its kind, Certara’s 900+ strong team of scientists, regulatory, and market access specialists have worked in virtually all therapeutic areas and modalities, including novel therapies and combination products, across the full range of regulatory pathways. With our quantitative and analytical approaches, we increase confidence in critical decisions to save time and money and advance drug safety and efficacy.
How we help our clients
Cardiovascular
Central Nervous System
Endocrinology
Immunology
Infectious Disease
Oncology
Orphan/Rare Disease
We design and implement drug development strategies using quantitative science such as pharmacometrics, clinical pharmacology modeling, and model-based meta analysis . Our integrated approach weaves together many disciplines including regulatory science and evidence, value & access so that we can anticipate risks and inform critical decisions to achieve major milestones.
- Get to proof of concept faster
- Optimize trial design
- Reduce trial size or avoid certain trials altogether
- Expedite regulatory submissions
- Expand patient access to medicines
We have scores of case studies and drug approvals to back our experience and success.
Drug development, the Certara way, is a team sport. The high quality and outcomes of our partnerships are the result of dedication, collaboration, and deep expertise.
By choosing to partner with Certara, you tap into the expertise and insights of leading drug development, regulatory, and market access experts who are committed to finding the right answers and increasing the probability of your success.
We navigate complexity through flawless execution and stewardship with our top scientists and experts in pursuit of your goals.