Evelina Rubinchik

Nonclinical pharmacology and toxicology services to biotechnology companies: • Development and implementation of nonclinical strategies for toxicology and pharmacology testing. • Selection of nonclinical CROs. Facility, procedure, and study audits. GLP compliance evaluations. • Preparation of project budgets and timelines. • Review, interpretation, and positioning of safety and pharmacology data. • Selection of experimental efficacy models to appropriately reflect human conditions under study. PK/PD analysis, optimal dosing, and risk/benefit assessment. • Interactions with regulatory agencies to ensure acceptability of product development plans. • Preparation of nonclinical documentation for regulatory submissions. • Technology transfer and due diligence evaluation.