Andrew S. Verderame, MBA, RAC leads the FDA Regulatory LLC Consulting group and is our Strategic Regulatory Affairs Advisor as we plan for and conduct our interactions with US FDA. He also serves on the Board of Directors at ViTalent Health Sciences. Most recently he was CEO at SciLucent, LLC and President/Partner with PharmaLex US, both highly respected pharmaceutical consulting firms. He has been active in the pharmaceutical industry since 1985 and previously held senior regulatory affairs positions at Merck Serono, Alexion and Bayer HealthCare. Andrew has personally led over one hundred meetings with FDA, managed multi-site global regulatory teams for both large and small pharmaceutical companies, led preparations and presentations to FDA Advisory Committees, with successful outcomes, and was responsible for numerous New Drug Application approvals from US FDA.