Bio

Expert in toxicological justifications and risk assessments of impurities in drug substances (APIs) and in drug products, by using literature justifications, computational toxicology, and toxicological studies. Specialties: Nonclinical regulatory requirements including ICH, FDA, and EMA impurity guidelines. Process related impurities and degradation products. Genotoxic Impurities. Extractables & Leachables (E&L) assessment. Elemental Impurities. Excipient evaluation and qualification (primarily when exceeding IID limits). Background in Medicinal Chemistry and patent evaluation of pharmaceuticals.