About

About Only Orphans Cote LLC Only Orphans Cote is the leading global orphan product development regulatory affairs consulting firm. Led by a former Director of the Office of Orphan Products Development, Dr. Tim Cote spearheaded the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on over 1,400 orphan drug designation applications. About Only Orphans Cote Only Orphans Cote is the leading global orphan product development regulatory affairs consulting firm. Led by a former Director of the Office of Orphan Products Development, Dr. Tim Cote spearheaded the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on over 1,400 orphan drug designation applications. Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases. 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. Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases. We crystalize our clients’ drug development work into regulatory tangibles. In doing so, we enhance asset valuation, investment attractiveness and exit options.