The Leader in Nicotine Regulatory Consulting & Compliance Solutions Around the World.
We are the leading experts in nicotine and U.S. FDA, Health Canada and EU regulatory compliance. With offices around the world, Chemular provides strategic, analytical, behavioral, toxicological, clinical and project management consulting solutions for all aspects of the regulatory process.
PreMarket Tobacco Applications (PMTA)
A PMTA (PreMarket Tobacco Application) is a comprehensive application required for submission for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug and Cosmetic (FD&C) Act.
The FDA considers, among other things:
Risks and benefits to the population as a whole, including people who would use the proposed product as well as nonusers;
Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new tobacco product were available;
The methods, facilities, and control used to manufacture, process, and pack the new nicotine product.
Services & Consulting Solutions
Full Suite of Regulatory Services
→ Substancial Equivalence (SE)
→ Modified Risk Tobacco Products (MRTP)
→ Tobacco Product Manufacturing Process (TPMP)
→ PACT Act & Tax Compliance
→ Health Canada (NHP)
→ European Union (TPD)
Reviews & Audits
→ Environmental Assessment Review
→ Ingredient Review
→ Literature Review
→ Regulatory Intelligence / Strategy
→ Toxicology / Chemistry / Lab Work