Management Team of Bluefinch Consultancy, European Regulatory Affairs Consultants

Bluefinch Consultancy Limited was set up in 2006 by Vincent Wek in response to the growing needs of pharmaceutical companies for good Regulatory Affairs consultants. In 2007 Richard Hill joined Bluefinch as a regulatory affairs consultant. Between them, they have over 12 years experience in European regulatory affairs in the ethical, generic and biotech fields. They have worked with many of the leading companies in the industry, including GlaxoSmithKline, Pfizer, Winthrop Pharmaceuticals (part of the Sanofi-Aventis group) and Generics UK.

They have a firmly based expertise in:

	European regulatory affairs procedures
	Regulatory strategy
	Regulatory project management
	Due diligence of dossiers
	Marketing Authorisation Application submissions (Centralised, Mutual Recognition, Decentralised and National procedures)
	Chemistry/pharmaceutical documentation
	Regulatory maintenance for ethical and generic products
	SPC and PIL harmonization
	CTA applications
	Risk Management Plans

Both Vincent and Richard have experience in the following therapy areas: anti-infectives, cardiovascular, CNS and Men's/Women's health.

Vincent has an MSc in Biochemical Engineering and a BSc (Hons) in Biochemistry from the University of London . Richard has a BSc (Hons) in Applied Biology from De Montfort University, Leicester and a background in the manufacture & analysis of pharmaceutical products prior to moving into regulatory affairs. Externally, both Vincent and Richard are members of TOPRA.

CVs of Vincent and Richard and of other Bluefinch consultants will be provided on request.

BLUEFINCH consultants maintain their current regulatory knowledge through ongoing contact with regulatory agencies, as well as through active memberships in various industry associations including The Organisation for Regulatory Affairs Professionals (TOPRA).

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