Regulatory Open Forum

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  • 1.  RIM for International Registrations

    Posted 09-Mar-2015 14:53
    Does anyone have a recommendation for a good Regulatory Information Management system for International Registrations for Medical Devices?  We are looking for a cloud based system compatible with Agile and Oracle.
    Need multiple countries capability (over 125) and thousands of products capability. (Over 2000).
    Thanks for your input!

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    Diane Rogers
    Manager of Regulatory and International Affairs
    Ultradent Products Inc.
    South Jordan UT
    United States
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  • 2.  RE: RIM for International Registrations

    Posted 10-Mar-2015 06:10
    Dear Diane, 

    We have recently implemented Samarind's RegTrack system corporate-wide for medical devices. They already had a pharma system, and we piloted the changes needed or the Medical Device system, and are quite happy with it. RegTrack is one of the systems they have available in the family of regulatory product documentation. You can look at their website at https://samarindrms.com/ or contact Miranda Pothiawala at Miranda@samarind.co.uk for further information. 

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    Kat Crowder
    Director of Regulatory Affairs
    Fresenius Kabi
    Lake Zurich IL
    United States
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