Changing the Game in Drug Development through a Strategic and Programmatic Approach
Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones makes clearing critical technical, regulatory, and commercial challenges precarious.
We see drug development as a team sport where clinical pharmacology helps bring the domains of expertise together with a renewed focus on regulatory science innovation. We focus on cost, time and certainty, all oriented to the patient need.
Your partner for regulatory and commercial success
Certara has helped sponsors bring more than 80 drugs to market over the past several years and advised hundreds of programs from early clinical development stages through proof of concept.
Those drug programs, for companies including both large pharma and emerging biotech, cover a range of therapeutic areas, including oncology, immunology, rare disease, CNS, metabolic and infectious disease. They address the needs of special populations (pediatrics, geriatrics, pregnant women) and global health challenges. They have been developed in accordance with the leading global regulatory agencies, such as FDA, EMA, and PMDA. And they have been executed under unique regulatory programs as breakthrough drugs, orphan designation and priority review.
The team we commit to your success
Our team of more than 300 PhD, PharmD, and MD scientists and regulatory writers can articulate the most compelling data-rich communications and submittal package. With each engagement, we provide the data-driven and regulatory science backbone with regard to a drug’s safety, efficacy, risk/benefit, and comparative effectiveness to increase your probability of regulatory and commercial success.
Certara’s talented, multidisciplinary team of experts cover these areas:
- Clinical pharmacology
- Translational medicine
- Early and late phase development
- DMPK, non-clinical and clinical safety
- Regulatory strategy and science
- Model-informed drug development
- CMC and formulation science
- Health economics and comparative analysis
- Epidemiological analyses
- Regulatory writing and submittal
Our strategic and programmatic approach to drug development leverages our scientific and regulatory expertise. Certara’s portfolio of quantitative and regulatory science technologies includes: