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Have you received a PMTA Deficiency Letter?

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, behavioural 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 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.

Use the following form below to get started.

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