Regulatory Affairs

Helping innovative companies obtain marketing approval for their Next Generation Nicotine Delivery Products (NGPs)

Regulatory Pathways

At Broughton, we advise the studies required for your chosen regulatory pathway. We conduct the studies, interpret the data, construct your regulatory dossier, and submit it through the relevant agency-specific system. Our team of regulatory affairs consultants understand the requirements of multiple regulatory pathways pertaining to nicotine products, and together with our scientific consultants present your data aligned with regulatory language to ensure that the data presented to the regulators is compelling to them.  Our regulatory affairs consultants understand the quality standards required for the entire product lifecycle and work with you to ensure that you are ready for any regulatory inspection that your product’s authorization may depend on. Our regulatory affairs consultants navigate your application through the entire process.

Dossier Compilation & Publication

Led by our scientific consultants with in-depth industry knowledge and guided by our regulatory affairs consultants, at Broughton we know that your regulatory dossier is as unique as your product. The dossier is the opportunity to tell the story about your product to the regulator, and the conviction of these words will optimise the quality of your submission. The question we always ask is why should a regulatory agency allow your product onto the market? The answer to this question will be carefully crafted into your dossier to ensure little to no doubt is left in the minds of the regulator with regards to the benefit that your product will bring to the market.

We ensure that your application is published to standards required by the various regulatory agencies and submitted in the correct format through the relevant submission system. Furthermore, we demonstrate complete traceability of your dossier. In this way, if subjected to a regulatory inspection, all versions of documents used in your submissions are fully traceable back to the earliest drafts.

We do not see dossier compilation as a filing cabinet full of data. We see the narrative as a piece of powerful strategic scientific communication that represents you, your company, your product and your science articulated into a compelling and thought-provoking argument.

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From basic questions to complex compliance inquiries, we're here to help! Contact us today.