Bio

Extractables and Leachables (E&L) Consultant to the Pharmaceutical Industry with a 30 yr career focused on E&L, providing consultancy, development and execution of strategies to fulfil the extractable and leachable requirements for global registration of generic and brand name pharmaceutical products. An analytical chemist & specialist in the study and assessment of E&L in Inhaled, Parenteral and Biologic pharmaceutical products. Providing development of E&L strategies, management of studies, authoring and review of regulatory submission & DMF sections. Accomplished in the design and implementation of E&L work packages, E&L risk assessment, analytical method development, validation and regulatory submission writing. Author and reviewer of E&L sections of multiple regulatory submissions.