Regulatory Open Forum

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  • 1.  Biologics in Canada

    Posted 07-Dec-2016 15:43

    Can anyone recommend a consultant for biologics in Canada.  Also, does anyone have a flow chart of the approval process in Canada available that they could share?  Bonus if anyone can share one that compares it to the US FDA process.

    Thanks!

    Marcy

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    Marcy Sussman RAC

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  • 2.  RE: Biologics in Canada

    Posted 08-Dec-2016 09:34

    We have been audited by John Simon and Associates from Edmonton, Canada. Very easy to work with. His website is Johnsimon.com.

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    Mridula Diwakar, ASQ CQA
    United States



  • 3.  RE: Biologics in Canada

    Posted 08-Dec-2016 15:05

    Contact Jan Sedgeworth at Intrinsik Health Sciences Inc. at jsedgeworth@intrinsik.com

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    Thomas Demelfi
    Director, Regulatory Affairs
    Atara Biotherapeutics
    Westlake Village CA
    United States