Regulatory Open Forum

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  • 1.  Regulatory Information Management tools recommendations

    Posted 27-Apr-2021 16:37
    Hello everyone,
    I would like to ask to recommend tools you use to keep track of the global license renewals, track registration progress, and obtain regulatory intelligence. Ideally those tools would come with some consulting services or in some countries - in-country representation. 
    Thank you,
    Anna

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    Anna Rashevsky
    Redmond WA
    United States
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  • 2.  RE: Regulatory Information Management tools recommendations

    This message was posted by a user wishing to remain anonymous
    Posted 28-Apr-2021 09:05
    This message was posted by a user wishing to remain anonymous

    We use RAMS from EMERGO to track everything and  they also do consulting/in country representation in most major countries. We use them for that too.


  • 3.  RE: Regulatory Information Management tools recommendations

    Posted 28-Apr-2021 16:17
    Thank you very much for the recommendation. Did Emergo help integrating RAMS with your systems? 
    Could you recommend contact there?
    Thanks!
    Anna

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    Anna Rashevsky
    Redmond WA
    United States
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  • 4.  RE: Regulatory Information Management tools recommendations

    This message was posted by a user wishing to remain anonymous
    Posted 29-Apr-2021 08:34
    This message was posted by a user wishing to remain anonymous

    Its more standalone, at least thats the way we use it.

    Are you thinking of an eQMS? They do receomend one in the tool.

    They have people all over (I'm not in the US) so best fill out the lets connect form at the bottom of here:
    https://www.emergobyul.com/rams


  • 5.  RE: Regulatory Information Management tools recommendations

    This message was posted by a user wishing to remain anonymous
    Posted 29-Apr-2021 08:34
    This message was posted by a user wishing to remain anonymous

    If you haven't reviewed Rimsys yet, I would recommend them for anything regulatory related.  I don't believe they provide regulatory consulting services, however.  There are plenty of consulting groups around if you are in need of one.