Successful delivery of PMTA requires regulatory expertise to ensure the project is aligned with regulatory needs. Our combination of scientific knowledge and analytical skills deliver an effective testing strategy for your PMTA process.
You will have a dedicated Project Manager who manages the whole process of your PMTA project covering regulatory, scientific and analytical activities.
Diagram 1 represents an overview of the various data submissions required for PMTA.
Diagram 1. PMTA Overview
Whilst our core competence sits with the Product Analysis element of PMTA, we have a network of trusted, specialist partners who can be introduced to your project to deliver an end to end service where required. By working with Broughton Nicotine Services we will optimise your regulatory submission while ensuring cost is kept under control.
A successful PMTA Product Analysis strategy can only be delivered following an effective planning stage.
At Broughton Nicotine Services we follow a four-step process and engage regularly with FDA.
Brochure
Download our brochure to read how Broughton Nicotine Services can help you comply with regulations requiring HPHC testing.
White Paper
Download our free white paper to get further information on the FDA’s Guidance for Industry on PMTA for Electronic Nicotine Delivery Systems (ENDS).
Brochure
Download our brochure for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.
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