Helping to shape the future strategy of regulated Next Generation Nicotine Delivery Product (NGP) markets.
The amount of scientific data required to launch a nicotine product depends on the jurisdiction you are looking to market your product and the associated regulations. The most complex jurisdiction that requires significant data is the U.S. via the PMTA or MRTP pathways. The U.S. FDA has issued guidance on what data is required for the regulatory assessment of the product. However, this can appear like a maze and be difficult to understand. Which studies are required, where scientific justification for the use of existing data can be used, and where empirical data might be required are all important questions to answer.
At Broughton, our scientific consultants with their deep-industry knowledge understand exactly what is required; study designs required to yield data and where data can be bridged from existing datasets. Their expertise lies in designing smart and efficient study protocols to generate the data you need quickly and efficiently. Together with our consultants’ extended networks, unique solutions to your unique products are never far away.
Our scientific strategy is essentially a mixture of deep scientific understanding of nicotine products, product engineering and regulatory alignment. You can be confident that once executed, the scientific strategy we define specifically for you and your product will give you the best opportunity of regulatory success.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.