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