Start-ups & Small Biotech

Coté 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. Led by Dr. Timothy Coté, former Director of the Office of Orphan Product Development at the FDA, the COC team adds value to organizations large and small through a range of services that fill the voids in in-house regulatory capacity. With a combined, deep knowledge of FDA’s inner working, the team can leverage drive and innovation into:

• Regulatory Strategy Planning
• Orphan Designation Applications
• Break Through Designation Applications
• Pediatric Priority Review Vouchers
• FDA Meeting Preparation and Representation
  • Pre-IND
  • End of Phase 2
  • Pre NDA/BLA
• IND Submission
• NDA/BLA Submission
• Patient Advocacy Group strategic planning
• Clinical Trials Design and Execution
• EU Orphan Designation Applications

COC works on a project basis in order to remove uncertainty and ensure the client has clear expectations and guidelines for what will be accomplished. After the initial consultation, a proposal for the scope of work and the fee for completing it will be prepared and presented to a client.

Although we encourage comprehensive packages, sometimes drug developers and other are interested in one-time conversations on one or multiple drug development issues. For this type of engagement, there is a one-hour minimum; hourly rates available upon request.