An overview of the full-service PMTA Program Delivery service provided by Broughton Nicotine Services, across all compliance workstreams.
If you are anticipating a letter and require supplementary data to support your Premarket Tobacco Product Application Submission (PMTA), now is the time to act. Once a Deficiency letter is issued you will have 90 days to respond to Food and Drug Administration (FDA) – not a long time when you consider that your response is likely to require the generation and interpretation of data.
Whether you are in the acceptance, filing or review stages of a PMTA application, we can help. At Broughton Nicotine Services our team of chemistry, toxicology, clinical, behavioral, and regulatory experts have worked with clients designing studies to generate the data required by FDA to demonstrate that your product is Appropriate for the Protection of Public Health (APPH).
We know that time matters during this stage of the process and our team are committed to work in partnership with clients to support their PMTA application; keeping your deemed products on the market and maximizing your chances of being granted a Marketing order.
Narrated by our Chief Regulatory Officer, Dr. Nveed Chaudhary, our useful videos explain what you need to know whether you have received a deficiency letter or are expecting to receive one:
We are on a journey together to ensure your products remain on the market and demonstrate to FDA that they are APPH. By working in partnership, we will make this happen. Collaborate with Broughton Nicotine Services to build on the foundations of your regulatory submissions and maintain compliance. Our mission is to accelerate safer nicotine-delivery products to market, advancing a smoke-free future.