Cote Orphan Consulting is a firm that has the expertise to assist with regulatory affairs, quality assurance and control, training and risk evaluation. Our in-house staff has experience in strategic marketing, project management and pharmaceutical research in order to successfully help our clients comply with FDA regulations in the development of orphan drugs. The COC team adds value to organizations large and small through the range of services that fill the voids in in-house regulatory capacity.
Start-Ups & Small Biotech
Whether it’s orphan drug designations or FDA regulatory meetings, COC forges successful pathways from orphan designation to marketing authorization.
Large Pharma & Established Companies
COC works with large companies on both one-time projects and retainers that permit for advising in various capacities on orphan drug development.
Financial Industry & Venture Capital
Orphan products face specific clinical development and regulatory challenges, but COC helps investors evaluate the risks and mitigate uncertainty.