Ann Godsell now runs her own Regulatory Affairs Consultancy. She has worked in the field of regulatory affairs for over 20 years, with further experience in the pharmaceutical industry in quality assurance prior to this.
She has worked for various companies in a wealth of roles, which have involved all aspects of regulatory, with projects relating to all stages in a product lifecycle from early clinical development through to working with established large commercially successful brands, managing regulatory affairs and providing both strategic advice and operational support.
Expertise in working in roles such as managing a major global product and site rationalisation programme, a company name change for a multinational company in various markets, development of company training schemes and introducing SOP systems and procedures, and with initiatives such as readability testing, and legal status switching of medicines.
This experience in pharmaceuticals covers a wide number of therapeutic areas, and also a wide variety of geographical markets, including the EU, the USA, South Africa, Australia and various other international markets.
Ann has been working with companies wishing to obtain registration following the introduction of the Traditional Herbal Medicines Directive (THMD). Support and advice is available on all aspects of such registration. She is a member of the board of the BHMA (British Herbal Medicine Association). Expertise includes advice on borderline issues, including whether product may be considered under food legislation with a health claim or as a cosmetic or medical device. Now increasingly more involved with supporting food health claims, especially for botanicals, since the introduction of the Nutrition and Health claims Regulation in the EU, and the borderline area between such claims for foods and potential medicinal claims.