ABOUT ONLY ORPHANS COTE REGULATORY CONSULTING
"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 services that will get your orphan drug to market.
Contact us now to see how we can assist you.
Our Team
Expert Regulatory Affairs Consulting for Orphan Drugs
Only Orphans Cote offers regulatory affairs consulting that bridges scientific innovation and real-world approvals. Our team transforms complex drug development plans into clear, compelling submissions that meet FDA and EMA requirements. From shaping regulatory strategies to guiding sponsors through designations, meetings, and expedited programs, we provide the insight and precision needed to move rare disease drugs toward marketing authorization — and ultimately, to the patients who need them most.
