broughton nicotine services

Have You Received, Or Are Anticipating Receiving, A PMTA Deficiency Letter?

Do you have the team in place ready for this stage?

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.

 

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FDA PMTA REVIEW PROCESS

Where are you in your PMTA application process?

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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.

Support includes:

  • Dedicated Project Manager to deliver within timeframe stipulated by FDA.
  • Regulatory and scientific consultancy support.
  • Close links with regulators and ability to interpret FDA requests.
  • Thorough understanding and experience of all PMTA workstreams.
  • Supplementary data generation and interpretation to fill data gaps.
  • A Contact Research Organization you can trust to deliver on-time.

WHICH VIDEO IS RIGHT FOR ME?

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:

 

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Have you received a Deficiency Letter

If you are in receipt of an FDA deficiency letter – select this video.

WATCH NOW

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Supplementary data to support your PMTA Application

If you are in the ‘accepted / filing’ stage of the FDA PMTA Process – select this video.

WATCH NOW

 

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.

 

Book a meeting with us today to discuss your requirements.