Your Partner for Strategic Biosimulation and Regulatory Writing Consulting

Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services.  The company includes more than 100 Ph.D. and M.D. pharmacometric experts, working on thousands of key modeling and simulation projects on behalf of hundreds of global biopharm companies. Synchrogenix, Certara’s scientific and regulatory writing consultancy employs 100 full time writers and a network of another 100 staff available to strategical support the full range of global regulatory submittal documents.  

Committed to Scientific Differentiation and Leadership

Our global scientific team applies quantitative analysis and predictive models of diseases, drugs and clinical trials to support strategic decisions and new drug submissions. Our scientists combine specialized clinical and regulatory knowledge and decision-support tools to optimize patient populations and doses and regimens, design optimal trials, evaluate safety risk, extrapolate virtual human data, optimize commercial competitiveness, and create clinical study reports and filing documents to expedite the drug development process.

Our commitment to scientific innovation is evidenced in the hundreds of peer-review papers written by our team. It can also be seen in our integration of 'bottom up' physiologically-based pharmacokinetic (PBPK) modeling with 'top down' pharmacokinetic/pharmacodynamic (PK/PD) approaches. We have incorporated models alongside trials to minimize the impact on clinical volunteers. We have also developed Model-Based Meta-Analysis and clinical outcomes databases to determine comparative effectiveness of new drug candidates and improve competitiveness. 

Unique Intersection of Biosimulation and Regulatory Writing

Justifying a biosimulation approach to the agency is both an art and a science. Successfully employing biosimulation requires addressing specific challenges in each therapeutic area while satisfying the sponsor’s overall business objectives and constraints.  Realizing the value of integrated biosimulation and regulatory writing requires the right group of people who can deliver this vision. Synchrogenix has successfully helped dozens of clients obtain drug approvals using this approach. Having technology-enabled pharmacometricians and strategic regulatory writers as part of a sponsor’s team will improve their chances of success. By harnessing the power of biosimulation and superior regulatory writing, Certara is reshaping the pharmaceutical industry’s approach to drug development.