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Paul Hardman

Managing Consultant - Chemistry

Paul joined Broughton having previously led product characterization studies for both consumer and medicinal products.

  • 10 years of experience in developing inhaled pharmaceuticals; across API particle engineering, formulation development and scale up, and device design including interaction with the formulation to enable products to target either systemic absorption or local effect in the lung
  • Passionate about product quality and understanding a products chemistry, from product design to its intended function, how the chemistry changes over time, and assessing any special features
  • Leading the European Committee for Standardization working group on extractable and leachable compounds in vaping products
  • Currently leading studies related to product chemistry across a wide range of consumer and medicinal products at Broughton

Paul is a Managing Consultant of Chemistry and manages a team of consultants specializing in understanding product chemistry and has experience spanning pharmaceuticals and consumer products.

Paul studied a BSc in Pharmacology from the University of Sheffield and commenced his career at Vectura, where experience was gained in developing dry powder inhaled medicines for a variety of conditions and designing the products to target local or systemic absorption. He was the co-inventor of a novel powder dispersion engine design for a passive dry powder inhaler, with potential for use across a range of API and with a range of inhalers.

Following ten years at Vectura, Paul led the Quality Control teams responsible for QC release of raw materials, finished products, componentry and packaging, and stability testing at one of Perrigo’s manufacturing sites. In this role, Paul transformed the processes to enable compliance to Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA) data integrity requirements.

Prior to joining Broughton, Paul led product characterization at Nerudia and Imperial Brands. This included assessment of Next Generation Nicotine Products (NGPs) spanning e-vapour, oral, and heated tobacco areas at all stages in the products lifecycle. In this role Paul has met with FDA to discuss e-vapour product chemistry approaches to meet Premarket Tobacco Product Application (PMTA) requirements, presented at Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA), designed studies to understand differences in the site of absorption of freebase and nicotine salt e-vapour formulations, and written regulatory packages to support the marketing of products in the UK, US, Japan, New Zealand, and the Middle East.

Paul Hardman