Business Profile

Description: BioPharma Global is a mission-driven corporation, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical need. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. We are a full-service FDA and EMA regulatory affairs firm specializing in diseases with high unmet medical need, meetings with the agency, IND Filings, and other expedited programs. We offer a host of services that help drug developers take full advantage of the benefits of developing therapies for rare and unmet medical needs in both the US and EU, including: • Orphan Drug designation (FDA and EMA) • Fast Track designation • Breakthrough Therapy designation • RMAT • EMA PRIME • FDA meeting assistance (Type A, B, C) • IND Filing • Gap analysis • Feasibility assessments • Regulatory Strategy Development To learn more, visit our website at http://www.biopharmaglobal.com or contact our Chief Operating Officer, Dr. Tom Ng, at tom.ng@biopharmaglobal.com or 1-202-660-6831.