Only Orphans Cote – Delivering Drugs through FDA and EMA
Description: Get expert consulting for FDA & EMA orphan drug designations and marketing authorization from Dr. Timothy Cote, CEO of Only Orphans Cote. Our team offers rare diseases and orphan drugs focus, regulatory services, strategies, and commitment.
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Delivering drugs through FDA and EMA
Orphan Drug Designations
Our flagship product. We write orphan drug designation (ODD) applications for both the FDA and EMA. With an ODD, the sponsor may receive economic benefits designed to support their drug development process and commercialization.
Only Orphans Cote – Delivering Drugs through FDA and EMA