ABOUT US

"Our Mission is Your Mission. To Present the Best Case For Your FDA/ EMA orphan drug designations and regulatory strategies leading to marketing authorization"

Located in the heart of Central Square, Cambridge, MA, the Only Orphans Cote's team helps to crystalize our clients’ drug development work into regulatory tangibles. In doing so, we enhance asset valuation, investment attractiveness and exit options.

Led by the former Director of the FDA Office of Orphan Products Development (OOPD) , Only Orphans Cote provides unparalleled orphan designation consulting service that will get your orphan drug to market

Contact us now to see how we can assist you.