We are a highly focused regulatory consulting group dedicated to the tobacco space and bring a world class team of tobacco-specific toxicologists, chemists, clinical trial experts in addition to project managers and other various subject matter experts to assist companies with their FDA and other regulatory needs. We offer complete or partial assistance with PMTA submissions, EU TPD fillings, PACT act compliance, SDS sheet creations, regulatory consulting advice and more. Founded in 2015, by experts in Tobacco, Pharma and U.S. FDA Compliance, our core team combines 50+ years of expertise in tobacco, medical, pharma, food, and cosmetics and has a successful track history with the FDA. Although focused on North America, we have established a global footprint including Europe and Asia enabling us to support at all levels including ingredients, design, software, manufacturing, and distribution.
