BioPharma Global is a mission driven corporation, operating like a not for profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug and device developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally recognized experts in the rare diseases and other underserved disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations, IND submissions and other expedited program submissions as well as regulatory Agency meetings to their credit. Additionally, our team provides expertise for all aspects of the medical device approval process, including strategy development and pre-market submissions. The BioPharma Global team currently has a greater than 97% success rate on submissions with the US FDA and EMA in Europe.
We maintain a completely customer-centric, transparent process through the entirety of our projects. We provide our clients a full suite of services which encompasses the best of scientific thought, management principles, and regulatory expertise with a reputation for creative solutions. By utilizing extensive medical writing resources, our highly skilled and experienced team provides medical oversight, ensures regulatory compliance, and supports the development of a wide array of documents/analyses.