Tobacco Risk Evaluation


Accelerated development for safer tobacco products

Evaluating Modified Risk Tobacco Products

For more than 17 years, Celerion has helped the tobacco industry evaluate potentially safer tobacco and nicotine-containing products. We have designed, consulted on, and analyzed samples and data for more than 120 studies. In the past six years alone, Celerion has analyzed over 350,000 samples collected from tobacco-product related clinical trials. We’ve developed 30+ assays—one of the largest fully validated list of assays in the field of tobacco research—to support clinical evaluation, making us uniquely positioned to help get your tobacco product to market.

 


Our Full-Service Approach

We can provide comprehensive services to evaluate your tobacco product including: study design, clinical conduct, bioanalysis, 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, automated bioanalytical methods and extensive experience with the endpoints assessed in clinical trials evaluating tobacco products also mean rapid turnaround on the data you need.

 


Regulatory Expertise and Research Investments

The regulatory and submission requirements for tobacco products continue to evolve and Celerion scientists remain vigilant to stay updated on changes to the regulatory landscape. We offer regulatory strategy support and assistance at agency meetings to ensure all relevant recommendations are addressed within your clinical program. We also invest in technology to stay at the forefront of tobacco product research. Collectively, these ensure that you receive fast, effective evaluations of your tobacco product.

What sets us apart from our competitors:

  • Custom clinical facilities with separate air handling to accommodate the requirements for trials involving indoor tobacco product use.
  • We have the most sensitive and selective validated assays in the field of tobacco research, with the highest throughput in the industry.
  • We are able to offer tobacco risk evaluation services that meet local statues, despite the tightening of indoor smoking laws that limit research in certain geographies.

FDA Guidance, Regulations and Compliance

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