Ishbel MacDonald, Director of MacDonald Regulatory Ltd.is a Food Scientist/Analytical Chemist, who has worked in research and development in academia and in the food and pharmaceutical industries since 1984. Prior to becoming a consultant in 2000, Ishbel was Director of Regulatory and Clinical Affairs at a start-up pharmaceutical company responsible for worldwide regulatory negotiation and approvals. Since going freelance in 2000, she has provided regulatory and technical advice to a wide range of pharmaceutical and food supplement companies in Europe, US and Far East. She enjoys working with Start-ups and SME’s specialising in regulatory strategy, gap analysis, Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), regulatory agency meetings, lifecycle management and regulatory due diligence. She is an experienced regulatory affairs trainer and currently teaches at the University of the West of Scotland and Glasgow University.


Key Services

  • CTA/IND/MAA/NDA submission / maintenance
  • Accessment of borderline products
  • Regulatory Strategy


Freelance Regulatory Affairs Consultant,
based in Glasgow

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