Regulatory Open Forum

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  • 1.  Regulatory Process in Russia

    Posted 11-Jun-2018 17:19
    I would like to have contact with anyone who has experience with the new drug approval process in Russia.

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    Glen Park
    Jersey City NJ
    United States
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  • 2.  RE: Regulatory Process in Russia

    Posted 12-Jun-2018 04:00
    ​Here is the list of some distributors, they may help you
    Best regards, Kinga

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    Kinga Kowalska
    Quality Manager
    Business Excellence, Quality & Regulatory
    Philips Innovation Services
    Andover MA
    United States
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  • 3.  RE: Regulatory Process in Russia

    Posted 12-Jun-2018 09:13
      |   view attached
    Hi there!

    I've attached current law (FZ.061) in English.
    There is also information on most recent updates:

    http://www.lidings.com/eng/legalupdates2?id=320

    https://excellishealth.com/wp-content/uploads/2018/01/Dec-28-2017-Russia-Amendments-introducing-TnT-English.pdf



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    Mariia Johnson
    Princeton NJ
    United States
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    Attachment(s)

    docx
    Federal Law RU.docx   197 KB 1 version


  • 4.  RE: Regulatory Process in Russia

    Posted 13-Jun-2018 08:27
    Hello Glen,

    If you have any specific queries on registering a new drug in Russia, you may contact me at:  purvigoradia314@hotmail.com

    I have extensively worked for Russia approvals for generic products recently.

    Would be happy to help you.

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    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
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