Companies in the Electronic Nicotine Delivery Systems (ENDS) sector in the US are required to submit a Premarket Tobacco Product Application (PMTA) by May 12, 2020. Given that this process can take at least 10 months to achieve a validated submission, now is the time to secure your team to deliver compliance. Our guide suggests the factors to consider when selecting partners to support your business through the PMTA program.
The process of seeking approval for a set of products is extensive, with a range of scientific, analytical and regulatory support required to achieve compliance. However, the potential return for businesses that take a pro-active and strategic approach to their PMTA is significant.
One of the most important contributors to a successful PMTA project, is securing the right partners and team for your business. Most likely, this will be a combination of people from within your own organisation and external specialist support. Some partners will provide full-service project management of the PMTA program on your behalf, from planning through to submission. Other companies provide support with one or more of the specific PMTA workstreams, to support your internal team.
Once you’ve identified the level of support you require, what are the top 5 considerations when selecting your team?
Are they experts in their area and the ENDS industry? Look for expertise in areas including Product Analysis, Toxicology & Human Behaviour Studies. Also, don’t forget Compilation and Legal Counsel. The advice and support of expert workstream leads will get your PMTA project off to a great start.
Can they give examples of similar successful projects delivered? How long have they been supporting ENDS companies? Do they have experience of engaging with the FDA?
Can they cope with the workload and are they there when you need them?
Is the team aligned with your business culture? In the fast-moving world of ENDS, can they cope with change and are they signed up to a smoke-free future?
Left until last, but likely to be the most important factor. Can you look them in the eye and believe that they will give you the best chance of success?
You might be thinking, where is COST? Of course, this is a consideration, but the commercial upside of a successful PMTA will vastly outweigh the cost to deliver it. Conversely, if you go with the cheap option and reduce your chance of success, why bother at all?