- Over 10 years of experience within the pharmaceutical industry in analytical method development, validation and contributing to regulatory submissions for inhaled and solid oral doses.
- Active involvement in European Committee for Standardization working groups for a wide variety of products and requirements.
- Passionate about applying his knowledge and experience to help clients accelerate life-enhancing products to market
Principal Scientist at Broughton, Paul works as a consultant specializing in designing studies for understanding product chemistry across pharmaceuticals and consumer products. In his consultant role, Paul is responsible for drafting regulatory submission documents and deficiency responses for PMTAs and is involved with study design and regulatory engagement with the MHRA for MAA projects. Paul studied a BSc in Analytical Science from Dublin City University. Paul started his career in Almac overseeing the method development, method validation, clinical release and stability testing of clinical supplies from phase I through to Phase III/PRE-commercial solid oral dose products. Following 7 years at Almac, Paul led the Analytical Method Development Team at Pharmaserve for 3 years overseeing the development of methods for pressurized metered dose inhalers. Prior to joining Broughton, Paul worked in the characterization team at Nerudia and Imperial Brands. As a characterization scientist Paul worked on Next Generation Nicotine Products (NGPs) spanning e-vapour and heated tobacco areas at all stages in the products lifecycle. In this role Paul designed scientific studies such as stability studiesto inform shelf-life claims. In addition, Paul drafted regulatory narratives and technical reports supporting regulatory packages to support marketing of products in the UK, US and Middle east. Paul is an active member of CEN standard group to raise standards of e-vapour products across the industry and assist in compliance to regulation.