Regulatory
Affairs

Helping companies get their innovative inhalation medicines to market.

Regulatory Pathway

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 pharmaceutical 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.

Our specialty lies in taking products from early stages of development to data collation across chemistry, pre-clinical and clinical scientific substantiation all the way through to regulatory dossier compilation and submission. When it comes to inhalation pharmaceuticals, Broughton will act as your strategic partner throughout the lifecycle of getting your product into the hands of patients and directly contributing to their wellbeing.

A Tailor- Made Service

Our consultants have experience in designing studies and analyzing data which can be used for medicinal applications around the world including the FDA, MHRA and EMA. Contact us for more information on how we can partner with you to develop your new product regulatory strategy aligned with your product development activities.

Contact us

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