Only Orphans Cote


Only Orphans Cote is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases. Under the guidance of Dr. Tim Cote, former Director of the Office of Orphan Products Development, we crystallize our clients’ drug development work into products and documents, securing FDA and EMA Orphan Drug Designations (ODD) as well as all other actions that advance to marketing authorization. In doing so, we enhance investment and asset valuation in the orphan drug market.