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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, 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 maximizing your chances of being granted a Marketing Order.

Support includes:
dedicated project manager

Dedicated Project Manager to deliver within the timeframe stipulated by FDA.
PMTA workstreams

Thorough understanding and experience of all PMTA workstreams.
FDA requests

Close links with regulators and ability to interpret FDA requests.
Product analysis

Product analysis and interpretation of data to fill data gaps.
Support

Regulatory and scientific consultancy support.
Contact Research Organization

A Contact Research Organization you can trust to deliver on-time.
Collaborate with Broughton to supplement your submissions and achieve compliance.

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

Need a consultation?

Contact us today to discuss your requirements for for a Contract Research Organisation (CRO) partnership

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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:
Nveed-Deficiency-letter

Have You Received A Deficiency Letter?

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

Supplementary

Supplementary Data For PMTA Application

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

Discover our videos, brochures, infographics and much more

Contact us

From basic questions to complex compliance inquiries, we're here to help! Contact us today.