Coté Orphan 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 Coté Orphan 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:
FDA Orphan Drug Regulatory Services:
- Orphan Designation Applications (ODD)
- Break Through Designation Applications
- Pediatric Priority Review Vouchers
- FDA Meeting Preparation and Representation
- Pre-IND
- End of Phase 2 Meetings
- Pre NDA/BLA
- NDA/BLA Submission
- Ad Comm Meetings
- Patient Advocacy Group strategic planning
- Strategic Reviews
EU Orphan Drug Regulatory Services:
- EU Orphan Designation Applications (ODD)
- Protocol Assistance
- Strategic Reviews
Coté Orphan 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.
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