Jeri is an expert in regulatory toxicology and Center for Drug Evaluation and Research (CDER) policies. She provides preclinical advice on scientific and regulatory issues in drug development, performs due diligence, and aids with strategic planning for drug development.  Jeri offers support in preparation of IND, CTD, NDA, and pre-IND submissions for the FDA. She is also experienced in carcinogenicity study design and evaluation, route of administration switches, and excipient, impurity, and metabolite safety testing issues.