Is PMTA worth your investment? Here’s an offer to help you decide.
We understand that committing your company to submitting a PMTA is not a decision that should be taken lightly, and we’re here for you with flexible solutions tailored to your business needs and budget. Our expertise in regulatory affairs comes from years of engagement with regulatory authorities and from a diversity of scientific backgrounds and experience.
Having submitted around 400 products under the PMTA process which have been accepted for scientific review, we know what’s needed to build a strong application.
Why work with us on your PMTA?
We provide unbiased regulatory consultancy and full end-to-end PMTA service – working with our testing partners to offer independent lab testing to give you confidence in your applications whilst keeping the process simple, reducing cost & ensuring clear communication with FDA at all times. Our process is straightforward and you’ll be assigned a dedicated project manager who will keep your application on track and update you every step of the way.
What we offer:
- Communication with FDA from the start to promote transparency and co-operation to reduce risk
- A simple robust seven module process which covers all requirements as specified by the FDA to ensure that your PMTA includes everything you need.
- Expertise in all areas requirement by the PMTA process: Manufacture / Toxicology / Clinical & Non Clinical / Chemical Analysis
- An experienced regulatory affairs team and lab collaborating to ensure that both product safety requirements, analysis and your application are correct.
Try our value for money no obligation offer to help you with your Pre-Submission Meeting (FDA Office of Science meeting)
We recognize the importance that smaller companies have in offering alternatives to adult smokers and want to ensure they have the opportunity to remain in the US Market.
Therefore, to help you assess whether it will be worth your while to make the full investment for a PMTA we want to help you with your kick-off Office of Science meeting with FDA – starting at $9,950 (and there will be no obligation to use us for the full submission).
We will hand hold you through collating the required information and the meeting to ensure that your regulatory strategy will tick all of FDAs boxes. We will prepare a bespoke strategy for your products, generate a project plan and timeline, and a detailed overview into potential project/product risks.
At the end of this process you will have a formal response from FDA detailing your project needs including consolidation of all clinical, toxicological and testing needs in addition to a detailed briefing document which forms the first step of your PMTA project.
Contact us today on +44 (0) 333 344 0201 or email@example.com to see how we can help you.