BioPharma Global is a full-service regulatory affairs consulting firm specializing in orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs. We offer services such as orphan drug designations and other expedited review programs, provide support for meetings with the FDA and EMA, IND filings, and comprehensive consulting on projects for regulatory strategy.
Our team is comprised of globally recognized experts in the rare diseases and other under-served diseases areas, including former FDA staff and a variety of scientists with many successful FDA interactions, orphan drug designations and other expedited program submissions to their credit. We operate like a not-for-profit company, maintaining a completely customer-centric and transparent process through the entirety of our projects.
Interested in learning how BioPharma Global may assist in your drug development efforts? Contact us today to connect with our expert team regarding your regulatory needs.
Rare Disease Regulatory Experts
Our regulatory team is led by our Chief Science Officer, Dr. Sandra Heibel, our Director of Regulatory Affairs, Dr. Lee Shaughnessy, our Director of Regulatory Affairs CMC, Ruth Hill, our Director of Devices and Combination Products, James Knox, and our Regulatory Affairs Manager, Antony Kaprielian. Dr. Heibel is globally renowned for her expertise in orphan drug regulatory affairs and has trained under Dr. Marlene Haffner, the former Director of the FDA Office of Orphan Products Development. Dr. Heibel has almost two decades of pre-clinical and clinical drug development and regulatory affairs experience specializing in rare diseases. Dr. Haffner served for over 20 years as the Director of the Office of Orphan Products Development and currently serves as active BioPharma Global board member and key advisor. Dr. Shaughnessy is recognized by many as one of the premier global regulatory specialists. Ruth Hill has over 20 years of experience in regulatory affairs with a focus on CMC. James Knox is a renowned expert in device and combination product regulatory affairs. Antony Kaprielian manages regulatory operations including all eCTD submissions and IND filings in addition to managing the in-house regulatory team.