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  • 1.  eCTD templates for Cell & Gene therapy IND

    Posted 08-Apr-2021 14:32
    Dear RA community,

    Can anybody suggest preferred vendor for eCTD templates catered towards cell and gene therapy INDs? I am looking for templates which comes with the instructions written for cell and gene therapy INDs, particularly for CMC sections. Most available eCTD templates have instructions for small molecules and biologics, not for the CGT products. Appreciate the input. 

    Thanks,
    Deep

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    Deep Shah
    Seattle, WA
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  • 2.  RE: eCTD templates for Cell & Gene therapy IND

    Posted 09-Apr-2021 17:59
    Hello Deep,
    I need the same information.  Let's see if we can get any comments, Regards, Lucyna

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    Lucyna Urbanczyk
    Kleinburg ON
    Canada
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    Original Message


  • 3.  RE: eCTD templates for Cell & Gene therapy IND

    This message was posted by a user wishing to remain anonymous
    Posted 12-Apr-2021 11:11
    This message was posted by a user wishing to remain anonymous

    You may want to try contacting Accenture that provides templates for eCTD including CGT products. Not sure what the cost would be or the contractual obligations.

    Another option would be contacting SBIA / FDA (if your company qualifies as SBIA) and be guided on where to begin.
    Original Message


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