Regulatory Open Forum

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  • 1.  Comparability Protocols

    Posted 30-Jan-2017 09:27

    We submitted a Comparability protocol for primary alternate components in a parenteral and received a Complete Response request from FDA. Does anyone know anyone that has experiences in dealing with Comparability protocols and answering deficiencies from FDA. This regulatory strategy is all new to us.

     

    Best regards,

     

    Leslie

     

    Leslie Fillion
    Regulatory Affairs Manager   
    Office:  +1.519.623.4800 x6354 | Email:lfillion@septodont.com

                                                                                                

    Septodont

    25 Wolseley Court, Cambridge, Ontario, N1R 6X3, Canada

     

     



  • 2.  RE: Comparability Protocols

    Posted 27-Mar-2017 10:48
    Hi Leslie, 

    Happy to set-up some time for you with one of Covance's regulatory/protocol strategy experts to help.

    Please feel free to reach out via the below. 
    Regards

    ------------------------------
    Dalbir Gill
    dalbir.gill@covance.com
    Regulatory Affairs
    Covance
    UK
    ------------------------------

    Original Message


  • 3.  RE: Comparability Protocols

    Posted 28-Mar-2017 11:18

    Hi, Leslie –

     

    I would also recommend Cato Research – they are a mid-sized CRO with a lot of experience helping companies with interesting challenges, including complete response letters.  Lots of experience in negotiating with FDA.

     

    For biologics, the Biologics Consulting Group also has extensive experience.

     

    Best of luck!

     

    Cathy

     

    ​​​​​

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC

     




    Original Message


  • 4.  RE: Comparability Protocols

    Posted 29-Mar-2017 05:21
    Hi Leslie,

    We can assist, too.

    Sincerely yours, Suzanne

    ------------------------------
    Suzanne Sensabaugh
    President and Principal Consultant
    Hartmannwillner LLC
    Washington DC
    United States
    ------------------------------

    Original Message


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