Tobacco Risk Evaluation

Evaluating Modified Risk Tobacco Products

For 15 years, Celerion has helped the tobacco industry bring new, safer products to market. We have designed, consulted, and analyzed data for more than 60 studies and, in the past three years alone, conducted over 200,000 analyses of tobacco samples. We’ve developed 30+ assays—the largest fully validated list of assays in the field of tobacco research—to support evaluation, making us uniquely positioned to help get your modified risk tobacco product to market.

Our Full-Service Approach

We can take care of everything while evaluating the risks of your tobacco product: planning and performing statistical analyses, interpreting data, and writing reports. This full-service approach creates continuity within your study, so that information carries forward into the next phase of the program, saving you time and cost. Our streamlined procedures and extensive experience with the endpoints of tobacco studies also mean rapid turnaround on the data you need.

Regulatory Expertise and Research Investments

The regulatory and submission requirements for modified risk tobacco products are always evolving. We leverage years of regulatory expertise to help you navigate these ever-changing pathways to product approval, working with various agencies (including the FDA, EMA, and MHRA) and staying updated on changes to the regulatory landscape through meetings with the FDA Center for Tobacco Products.

We also make a lot of investments to stay at the forefront of tobacco risk evaluation research. These are a few we’ve made to ensure you receive fast, effective evaluations of your modified risk tobacco product:

• We’ve made significant investments in tobacco harm reduction research, including a new, patent-pending approach for testing e-cigarettes.
• We’ve equipped our tobacco risk facilities with 278 beds to meet FDA submission requirements for trials involving indoor smoking.
• Not only do we have the largest list of validated assays in the field of tobacco research, but we also maintain the widest variety of exposure marker assays.
• Despite the tightening of indoor smoking laws, we are able to offer tobacco risk evaluation services through statutory laws, unlike many of our competitors.