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  • 1.  Drug Master Files

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jul-2019 10:19
    This message was posted by a user wishing to remain anonymous

    Hello, 

    Industry ballpark figure - does anyone know how much it should cost for a consultant or external regulatory firm to complete a DMF?  

    Thanks!


  • 2.  RE: Drug Master Files

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jul-2019 09:34
    This message was posted by a user wishing to remain anonymous

    What information do you wish to include in the DMF - facility/equipment, drug substance manufacture, etc?

    Do you have in-house publishing for electronic submissions, and a gateway?

    Are your source documents clean and easy to understand, and any SMEs cooperative?  Do you have word copies of source documents, properly formatted?
    Original Message


  • 3.  RE: Drug Master Files

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jul-2019 13:04
    This message was posted by a user wishing to remain anonymous

    Thank you for the additional questions, see below.

    It would by a Type II - Initial submission. In-house eCTD submissions w/gateway. We are initialing working with this "sponsor" on the pre-clinical and IND.  The documents should be easy to understand and will readily available to us in a Word Document (we will format).

    Thanks​
    Original Message


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