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 maintain 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 Scientific Officer, Dr. Paula Garcia-Calavia and our Regulatory Affairs Operations Manager, Antony Kaprielian. Dr. Marlene Haffner, the former Director of the FDA Office of Orphan Products Development, also serves on the board of BPG. 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. Paula is involved in feasibility and strategy consulting, novel data analysis, authoring expedited approval applications to FDA and EMA, project management, writing pre-IND and IND level submissions to FDA, and preparing clients for Type B FDA meetings. Antony Kaprielian manages all regulatory operations including all eCTD submissions and IND filings in addition to managing the in-house publishing capabilities.