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. The Coté Orphan team adds value to organizations large and small through the range of services that fill the voids in in-house regulatory capacity.

Orphan Regulatory Affairs

Whether it’s orphan drug designations or FDA regulatory meetings, Coté Orphan forges successful pathways from orphan designation to marketing authorization.
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Clinical Trials

Coté Orphan is now helping organizations navigate the clinical trials process through the lens of regulatory affairs as a Clinical Research Organization (CRO).

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