~ Key considerations for designing electronic cigarettes and other inhaled nicotine-containing products as medicines ~.
![](https://www.broughton-group.com/hs-fs/hubfs/iStock-1415564652-1.jpg?width=696&height=400&name=iStock-1415564652-1.jpg)
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.
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.
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.
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.
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.
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.
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.
Learn more about our activities and gain insight from our scientific and regulatory experts
3 minute read
~ Key considerations for designing electronic cigarettes and other inhaled nicotine-containing products as medicines ~.