Sukhy Toot, BSc(Hons), Applied, Chemistry

Mrs Sukhy Toot, BSc(Hons), Applied, Chemistry Smithers Rapra Medical & Pharma Services 425 West Market Street Akron, OH USA 44303 Email: stoot@smithers.com Biographical Sketch: Sukhy Toot, Product Manager – Medical & Pharma Services, consulting and coordination of extractables and leachables studies for pharmaceutical and medical device industries. I am a Chemistry graduate with 15 years of experience within the pharmaceutical industry. These were gained as a research scientist in the development and testing of inhalation products and materials characterization within Sanofi-Aventis; and as a development team leader for orally inhaled and nasal drug products (OINDP’s), ophthalmics, and sterile manufacture within Teva. My strong leadership and working knowledge of regulatory requirements in this area, gained through the commercialization of numerous drugs, are valuable in providing efficient and effective analytical solutions to clients in the Pharmaceutical and Medical Device industries, with particular emphasis on Extractables and Leachables testing of polymers. Here I have led the compilation of relevant sections of regulatory dossiers and responses to agency questions around container closure systems and product leachables.