Introducing the Tobacco Product Manufacturing Process The U.
Our Commitment to a Smoke-Free Future
For decades, the only way to consume nicotine was to release it by burning and smoking tobacco. However, this releases thousands of other compounds known to cause smoking-related diseases. Science and innovation mean nicotine can now be consumed without the burning of tobacco.
By helping our clients demonstrate to regulators the reduced risk potential of their next generation nicotine delivery products (NGPs) we can accelerate these products to market and support the elimination of smoking to promote better health outcomes.
Years of NGP Industry Experience
Learn how we have helped companies from the U.S., Europe, the United Kingdom, China, and the Middle East achieve marketing authorizations for their next generation nicotine products through the PMTA, TPD, TRPR, MRTP, and MAA regulatory pathways. As the first contract research organization to work on a successful MAA for an NGP, our consultants will bring years of industry experience to your NGP product realization or regulatory project.
- Subject matter experts with years of NGP-related experience
- Several successful NGP regulatory projects completed
- PMTA marketing authorizations won
- Over 375,000 Analytical Tests, 700 Environmental Assessments, and 300 Toxicological Profiles completed to support client PMTA applications
- Analyzed over 50 individual devices and e-liquids product units across various brands for PMTA applications
- Analytical testing, scientific strategy and regulatory compliance consulting for E-vapour products (EVPs), Heated Tobacco Products (HTPs) and Modern Oral Nicotine Products (MONPs)
Recent marketing order decisions by the U.S. Food and Drug Administration (FDA) for clients we work with have given us unrivaled insight into the regulatory benchmark needed to be authorized for sale in the North American market. By utilizing our deep knowledge of the UK/EU MAA and U.S. PMTA pathway, we can now offer a dual-track solution whereby studies can be done only once to support both UK/EU and U.S. marketing authorizations to help you save time and money in your next NGP regulatory project.
Improving the Lives of Smokers
Accelerate your next NGP innovation to market within your chosen regulatory framework with the help of our analytical testing expertise, product realization insights, and scientific consultancy knowledge. Ensure your NGP is designed from its early concept phase aligned with your chosen regulatory pathway to save time and costly technical reworks at later stages of development. Ensure your long-term product roadmap is built with regulatory pathways and submission deadlines in mind and has a comprehensive scientific strategy to bridge regulatory submissions to reduce time-to-market and investment in scientific testing across different product iterations.
A smoke-free future where smokers can switch to alternative nicotine delivery products that are scientifically proven to be less harmful is possible. By helping to accelerate your new NGP innovations to the market, we aim to help improve the lives of millions of smokers.
Analytical Testing for NGP
High-quality analysis and accurate test data from our scientific experts ensure you have the confidence and insight necessary to make informed decisions at every stage of your NGP development, regulator submission, or post market compliance project. From quality-controlled sample handling to analytical testing excellence, in-depth analysis, and problem-solving, our experts are there with you every step of the way to ensure the smooth and timely execution of your project.
Scientific and Regulatory Consultancy for NGP
Working with a bespoke integrated team of cross-functional regulatory scientists, you will have access to the right expertise at each stage of your NGP project. Your individual Technical Project Lead will bring years of industry experience and insight to ensure smooth transitions between different stages in the development lifecycle or regulatory compilation process, improving project efficiency and timelines. Whatever your NGP requirements, you’ll have access to the best scientific and regulatory experts, with years of experience working on regulatory projects, to help de-risk the project and solve any roadblocks in partnership with your in-house team.
Benefit from tailor-made scientific strategies and expert advice across product realization, regulatory submission, and post marketing compliance projects to help speed your NGP innovation to market and achieve commercial success. Move from just focusing on regulatory compliance in a chosen market to developing a global regulatory strategy for your NGP roadmap that will give you a competitive advantage and enhance your brand position with regulators and customers.
Whatever your chosen regulatory pathway, we are here to help you succeed.
- U.S. Premarket Tobacco Product Application (PMTA)
- U.S. Modified Risk Tobacco Product (MRTP)
- Medicinal Product
- European Tobacco Products Directive (TPD)
- UK Tobacco and Related Products Regulations (TRPR)
- European Medicines Agency (EMA) Marketing Authorisation Application (MAA)
Nicotine Services Resources
Learn more about how we can help bring your next generation nicotine delivery product to market through high-quality analytical testing integrated with expertise in scientific strategy and an understanding of global regulatory pathways.
PMTA Guide For NGP businesses
At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.
A Guide To TPD and TRPAn overview of the Tobacco Products Directive and Tobacco-Related Products Regulations. Get the straightforward answers you’re looking for when it comes to TPD and TRPR analysis.
Next Generation Nicotine Products Service GuideWe help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance.
Nicotine Industry Insight and Expert Opinion
Learn more about our activities and gain insight from our scientific and regulatory experts
VApril 2023 House of Commons Reception – How can VApril be used to support improvement within the vaping industry
Yesterday I attended the UKVIA reception at the House of Commons to launch this year's VApril campaign.
Ben Green, a Broughton Program Manager working on large nicotine-related regulatory projects, writes on the latest move by FDA to enforce against ....