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Only Orphans Cote LLC
Cambridge, Massachusetts, United Statesonly-orphans-cote.com ↗
- Ownership
- Private
- Development stage
- Other
01
Overview
Only Orphans Cote LLC specializes in regulatory affairs consulting for orphan drug development. Led by Dr. Timothy Cote, former Director of the FDA Office of Orphan Products Development, the firm assists biotech and pharma companies with FDA/EMA orphan drug designations, IND submissions, expedited program applications, and overall regulatory strategy for rare disease products. The consultancy boasts a high success rate (>90%) in obtaining orphan designations for its clients and has supported over 120 new clients since its founding in 2021.
- Therapeutic areas
- Rare Diseases
- Modalities
- All therapeutic modalities (for orphan drugs)
- Industry
- Drug Discovery Services
02
Partnerships
No major disclosed pharmaceutical or biotech partnerships; works with numerous client companies on a consulting basis.
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