Regulatory Open Forum

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  • 1.  EU Orphan Drug Sponsor

    Posted 04-Jul-2014 09:40
    I am working with a small virtual startup that is wanting to obtain Orphan Designation for an early stage product in the EU.  They have already received Orphan Designation in the US. Also they are not planning on conducting any clinical trials in the EU at this time.  

    As I understand it the company needs someone to be the Sponsor who resides in one of the EEA countries.  Does anyone have a recommendation on who they have used to act as a Sponsor?  I know of several law firms that do this but they tend to charge more money than this startup can afford.  

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    Richard Newman PhD
    Principal
    RND Services, LLC
    Deerfield IL
    United States
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