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.
Collaborate with Broughton Nicotine Services to create the foundations of your regulatory submissions and maintain compliance.
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:
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
LeafletDownload our brochure for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.
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.