PMTA Submissions


By 9th September 2020, the FDA required companies to submit a Pre-Market Tobacco Application (PMTA) for all existing products on the US market. It is now a legal requirement to submit a PMTA and gain marketing approval for all new products before they can be sold in the US.

A full PMTA submission requires significant time and investment. Therefore companies are advised to choose their partners wisely.

Hall Analytical have developed and validated methods for all of the analytes listed in the guidelines. With a view towards “other constituents, as appropriate”, we have added extra analytes that we deem to be of toxicological concern.

Although independent, we work in partnership with leading toxicology and regulatory consultants in the interest of product security. This enables us to provide a complete end-to-end PMTA service. We also offer a full TPD notification solution.

Keep your ENDS franchise ahead of regulation and request a consultation today.


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PMTA

What does the FDA’s finalised PMTA guidance mean for your testing?


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