Ewan Norton

Senior Consultant, GxPAssure

Ewan Norton is a seasoned pharmaceutical quality and GMDP compliance specialist with over 31 years in the industry, including over 12 years as an inspector with the MHRA, with his last five years as a Lead Senior GMDP Inspector. Accredited across APIs, non-steriles, IMPs, blood establishments, herbals (including cannabis sites), GDP, importation, and PLPI.

Ewan has led 350+ UK, EMA, and joint global regulatory inspections (WHO, FDA) and specialised in sites with serious compliance challenges. At the MHRA, he contributed to major regulatory initiatives including Compliance Monitoring, the Remote Inspection process, and inspector training in PQS data analysis. Ewan also served on the MHRA Inspection Action Group (IAG) for over three years, and the EMA PAT/Continuous Manufacturing team for two years.

Before joining the MHRA, Ewan spent 19 years in industry across both global pharma and smaller innovators – leading large Quality teams, and gaining hands-on manufacturing experience in APIs, cytotoxics, and biologics/ADCs.  Widely recognised as a confident and engaging presenter, he has delivered MHRA perspectives internationally across the UK, Europe, India, and China.