Experience & Achievements

Since 1985, initially  I have worked in the pharmaceutical industry initially as an analytical chemist then as a project manager progressing into regulatory and clinical affairs in 1992.
From 2000, I went freelance offering my experience and knowledge as an independent Regulatory Affairs Consultant, based in Glasgow. My key achievements to date include:           

  • Successful regulatory submissions in the USA and Canada and via the Mutual Recognition Procedure (MRP) including repeat use, submissions in Switzerland and many other territories
  • Successful appeal to the UK Medicines Commission
  • Involved in establishment of agreements with trading partners and commercialisation of a novel product
  • Experience in CTA/IND/MAA/NDA submission and maintenance
  • Liaison with active ingredient suppliers via Drug Master File system (US and Europe)
  • Post-approval/life cycle management experience in UK, EU and USA
  • Successful Reclassification applications (P to GSL) in UK
  • Preparation of Development Strategies/TPP’s
  • Identification of Scientific Advice (SA) issues with subsequent management of SA procedure(s)
  • Preparation of PSURs
  • Preparation and presentation of training courses on the role of Regulatory Affairs in Product Development
  • Assessment and follow-up of products that sit on borderline between foods and medicinal products, including dietary supplements, ‘medicinal’ foods, food additives, processing aids
  • Member of TOPRA since 1993
  • Established client base in UK, Europe, North America and Singapore