My expertise is in preparing or responding to FDA questions about preclinical study design or outcomes.  I help navigate preclinical and clinical questions by marrying policies and procedures with pragmatic clinical and scientific discussion of the data.  In new study design, the efforts are targeted at optimizing research outcomes while reducing animal numbers and regulatory burden. I also work with or help select a contract test site (CRO) to help you initiate or complete the animal testing necessary to attain a regulatory clearance/approval.