Report

August 13

Measuring up

Broughton Nicotine Services, Chief Scientific Officer has recently published an article with leading sector publication Tobacco Reporter – Measuring up

Measuring up – size matters!

As the US market gears up in for an industry shake up, Electronic Nicotine Delivery Systems (ENDS) companies are preparing their premarket tobacco product applications (PMTA) for submission.

Chis Allen, Chief Scientific Officer at Broughton Nicotine Services discusses how businesses are supporting clients with their regulatory requirements.

Earlier this year the Food and Drug Administration (FDA) announced an extension period of 120 days to their earlier May 12, 2020 deadline to cope with issues relating to the Covid-19 pandemic. Since the announcement, there has been an increase in demand for Contract Research Organisation (CRO) and laboratory services and the industry has stepped up to deliver. For ENDS companies, this period of grace has given those that had been delaying the PMTA process, or planning to submit partial information, additional time to commit fully to the PMTA pathway.

Businesses have had more time to better understand the whys and wherefores of their products and legislation to ensure they are appropriate for the protection of public health.

The amount of data generated and collated for a PMTA is phenomenal, tens of thousands of pages prepared ready for FDA substantive review. Undoubtedly, this is one mighty challenge for ENDS companies, CROs and the FDA and these are applications where quality and size really does matter.

You can read the full article here:

Measuring Up: How Instrumentation Suppliers And Laboratory Service Providers Are Supporting Customers With Their PMTA Submissions.

To discuss pro-active strategies to ensure the regulatory compliance of your products, request a meeting with our team.

About the Author

Chris Allen is the Chief Scientific Officer at Broughton Nicotine Services. Since obtaining a Bachelor of Science degree in chemistry, Chris has gained over 20 years of analytical and regulatory experience working in global Medical Device and Pharmaceutical companies and within leading Contract Research Organizations. Chris co-founded Broughton Nicotine Services sister company (Broughton Laboratories) in 2006 and played a pivotal role in obtaining the first UK Medicinal License for an Electronic Cigarette, a project starting in 2010. Now with over ten years of working with ENDS, Chris has become well established as a recognized SME in the regulations and chemistry of tobacco products. In the position of Chief Scientific Officer, Chris’ key objective is to support the acceleration of safer nicotine delivery products to market and to deliver value and unrivalled experiences to our customers.