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Global Regulatory Services

Clinical Trials >> Compliance, Regulatory & Consulting >> Tobacco

Leveraging our regulatory experience and familiarity with the tobacco industry, allows us to assist clients as they navigate the evolving regulatory pathway toward product approval.

The U.S. Family Smoking Prevention and Tobacco Control Act (FSPTCA) defines a Modified Risk Tobacco Product (MRTP) as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco related disease associated with commercially marketed tobacco products” (Family Smoking Prevention and Tobacco Control Act). Regulatory requirements for reduced exposure and modified risk tobacco products are evolving across the globe, and submissions to regulatory authorities are a part of this changing environment. Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. Researchers have extensive experience in developing and validating assays focused on the tobacco related study. Various assays have been developed to support clinical studies, Pharma companies maintains the wide variety of exposure marker assays. Within the field of tobacco research, companies also have the largest fully validated (to meet GLP requirements) list of assays. Clinical Research companies has also developed a number of biomarker assays including total aromatic amines, the lowest LLOQ available for 3-hydroxy benzo[a]pyrene (50 fg/mL), the lowest available LLOQ for total NNN (200 fg/mL), and the most selective nicotine equivalent in human urine assay available today. As a proactive strategy pharma companies are developing methods to quantitate 8 polycyclic aromatic hydrocarbons in human urine, propylene glycol in human exhalate and plasma, glycerine in human exhalate and plasma, and a series of panel assays measuring the biomarkers of multiple tobacco related disease states. In addition to delivering world-class tobacco science, bioanalytical laboratories lead the industry in validating assays that are compliant to regulated GLP/GCP guidelines. clinical laboratories use fully validated data management systems that include a paperless electronic laboratory notebook. With a commitment to investing in the latest LC-MS/MS technology and robotics. Companies have proven track-record in successfully evaluating potential reduced exposure tobacco products that can be applied to their clients’ programs of clinical studies. Their experience working within the evolving tobacco regulatory landscape, allow them to assist their clients, for different regulatory requirements or submission authorities. The value they provide to clients’ tobacco product clinical studies starts with highly skilled scientists who partner with our clients to plan the events and endpoints to be evaluated. Scientists are also responsible for planning and performing the statistical analyses, interpreting the data, and providing the written report describing the results. This full service approach enables continuity within a study and allows information to be carried forward into the next study in the program, thereby saving our clients’ time and cost. An extensive experience with endpoints commonly evaluated in tobacco studies and streamlined procedures allow for a rapid turn-around of data and reports. Clinical researchers constantly monitor industry trends and pertinent regulations as well as attend key scientific conferences to enable the scientific objectives of our clients’ studies meet regulatory requirements.

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