Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. Coté Orphan knows the FDA hurdles unique to orphan products and forges successful pathways to regulatory success.
Orphan drugs are the most exciting opportunity in drug development. Today nearly 40% of all new product market approvals the FDA grants are for orphan products. Orphan drug development is different; it involves special regulatory affairs, special drugs, special financial metrics, and special science. Unique experience is required to work with orphan drugs, experience not usually found amongst those who traditionally develop drugs for common diseases. Now your company has the opportunity to harness this special knowledge with unparalleled expert training from an insider, the industry leader in “orphanology”, former FDA Director of the Office of Orphan Product Development, Dr. Timothy R. Coté.
Our Philosophy: Unflinching Honesty
Great products begin with strong science, and although good science is necessary, without the proper regulatory support it can also be insufficient. In order for a product to be commercially successful it must be deemed worthy by the FDA for marketing authorization. Coté Orphan is not hesitant to plainly state the regulatory realities that may challenge, or conversely enable, the development of an orphan product. We know how the FDA thinks, we know the right approach, and we’re ready to help.