With 400 applications accepted for further scientific review for our clients, we’re confident that our thorough approach to PreMarketing Tobacco Applications has provided strong applications to allow our clients to keep their products on the US market and continue to grow their business.

We’re proud to say that our seven module approach ticks all the boxes according to the PMTA requirements set out by the FDA.

One of the first steps we take when working with our clients on your PMTA is to organise an Office of Science meeting with the FDA on their behalf. This consists of a meeting request as well as product information, questions to ask the Center for Tobacco Products (CTP) and a briefing document details of your products.

Engaging with the FDA early in the process promotes transparency and shows co-operation in that our clients are happy to comply with the regulations set out by them. 

One piece of feedback we’ve heard from clients who initially worked with other agencies and have subsequently had it rejected due to inefficiency – is that the applications were not as scientifically robust or in-depth as ours.

We conducted thorough research prior to developing our PMTA service to ensure that our clients’ applications contained all the information required by the FDA. 

While some regulatory agencies have advised that nonclinical research must be conducted, we understand that the information needed can be obtained from literature reviews which consider previous research published by accredited bodies and must meet specific criteria before we use them including relevancy, legitimacy and modernity.

This saves our clients time and money – which we know is much appreciated by any company going through this process!

Our in-house regulatory affairs team includes experts in toxicology, biochemistry, electronics and environmental science.

For each module of your PMTA, members of our team who specialise in the relevant area are assigned to researching, building and reviewing that area to ensure it’s accurate and covers all required information.

This full circle approach ensures your PMTA not only includes everything needed to be accepted by the FDA, but that your experience of the process is seamless.

We recognize the importance of small businesses in offering alternative products to adult smokers, and want to ensure they have the opportunity to remain in the US Market.

We keep regular contact with our clients to ensure that they’re kept updated on their application, and if at any point we feel there’s any risk of the application not being approved we work with them to put corrective action into place to ensure that it is.

When you choose us for your PMTA, you’re choosing regulatory expertise, a proven strategy and a team who will put the needs of our clients first.

Our experienced regulatory affairs and lab collaborate to ensure that each application is built effectively, your own project manager is allocated to ensure that things move forward on schedule and our clients are kept updated every step of the way.

As FDA continues to publish further PMTA updates, we’ll be the first to let you know.

To learn more about how we can support you with your PMTA, click here to learn more about our PMTA service or contact cara.leach@inter-scientific.com.

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