Do you have the team in place ready for this stage? If not, now is the time to act. Once a Deficiency letter is issued you will have 90 days to respond to FDA – not a long time when you consider that your response is likely to require the generation and interpretation of analytical data. 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 during Substantive Review.

We know that time matters during this stage of the process, our team are committed to work in partnership with clients to support their PMTA process; 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 the timeframe stipulated by FDA.
  • Thorough understanding and experience of all PMTA workstreams.
  • Close links with regulators and ability to interpret FDA requests.
  • Product analysis and interpretation of data to fill data gaps.
  • Regulatory and scientific consultancy support.
  • A Contact Research Organization you can trust to deliver on-time.

Collaborate with Broughton Nicotine Services to create the foundations of your regulatory submissions and maintain compliance.

"We work with you to develop and deliver regulatory strategies that meet your business goals."

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Which video is right for me?

Narrated by our Chief Regulatory Officer, Dr. Nveed Chaudhary, our useful videos explains what you need to know whether you have received a deficiency letter or are expecting to receive one:

 
Deficiency-letter-computer-screen

 

Have you received a Deficiency Letter?

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

WATCH NOW

Supplementary-data-computer-screen

 

Supplementary data for PMTA application

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

WATCH NOW

Why our clients work with us

We believe in nurturing collaborative relationships with our clients, and we strategically align our services with their business goals. We are here to provide you more than just data, our team of scientific and regulatory experts will help you design strategies aligned with achieving regulatory compliance for your products

Resources

Leaflet

Download our brochure for an overview of our comprehensive services to support the NGPS industry from regulatory submission to maintaining compliance.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

 

Brochure

The Food and Drug Administration (FDA) recommendations and requirements in this final ruling for Premarket Tobacco Product Applications (PMTA) are summarized in a downloadable report.