Dr. Kevin Ruby, M.S., Ph.D., was employed as a Senior Staff Reviewer with the United States Department of Agriculture Center for Veterinary Biologics (USDA CVB) for 35 years and has reviewed approximately 40,000 documents required for licensure of domestic manufactured products or permitting of foreign manufactured products of every type. He has licensed or permitted approximately 100+ products during his tenure at the CVB. Since retirement in 2021, Dr. Ruby has been a consultant for CVB, LLC, responsible for assisting manufacturers with licensing issues ranging from initial submissions, drafting Outlines of Production, Supplemental Information Formats, study designs, protocol/final reports, labeling, jurisdictional and USDA CVB issues. Dr. Ruby’s role at CVB, LLC will allow the foreign manufacturer to have access to statistical and inspection & compliance experts.