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  • 1.  Arazy Group

    This message was posted by a user wishing to remain anonymous
    Posted 17-Aug-2018 14:15
    This message was posted by a user wishing to remain anonymous

    Hello Colleagues

    I am looking for a medical device regulatory consultant company that offers registration, license holder, and authorized representative services in many countries on all continents so that I can minimize needing to work with too many companies.  Through the magic of Google, I have found that Arazy Group has a presence in many of the countries that my company wants to target, but I have never heard of Arazy.

    Has anyone out there used Arazy, and if so, I would appreciate to hear about your experience (good and not so good).

    Thank you for your input!


  • 2.  RE: Arazy Group

    Posted 19-Aug-2018 04:12
    Hello,

    My company uses the service of Arazy group as authorized representative in Europe for many years. We are satisfied and never had any issues with them- they were always very responsive to our requests and always answered fast- so I recommend them.

    Good luck!

    ------------------------------
    Taly Vider Cohen
    Regulatory and QA Manager,
    Medical Electronic Systems, LTD
    ------------------------------

    Original Message


  • 3.  RE: Arazy Group

    Posted 20-Aug-2018 11:29
    Hi,
    IRIS Global it is a regulatory consulting firm that specializes and understands the regulatory environment across Latin America, Central America and the Caribbean and ROW.  Just as important, we also understand the culture and business practices that are required to be successful, from the smallest island nation to the powerhouse of Brazil.
    Bases on the expertise we have of over 30years, we can answer your regulatory questions for a specific country or for the entire region.  We can prepare your product dossiers, file in-country, respond to health authority questions and monitor a submission's progress through approval. Maintenance of the license can be optimized and streamlined. We can act as the outsourced regulatory affairs group.   With our team in the U.S. and our specialists in all the countries, we offer a full set of capabilities that are normally only available to the largest companies. We can work with the in-house team to best manage your global regulatory needs, queries and approval strategies.

    Let us know if we can be of any help.
    IRIS GLOBAL LLC
    infora@irisgra.com

    ------------------------------
    IRIS GLOBAL LLC
    infora@irisgra.com
    ------------------------------

    Original Message


  • 4.  RE: Arazy Group

    Posted 21-Aug-2018 02:11
    Hello

    I can't speak to Arazy, but we offer such product registration services. 
    http://www.qservegroup.com/en/services/expertise-fields/global-registration

    We have offices in The Netherlands, USA and China and, more importantly, more than 40 partners around the world to help with local registrations. 

    We've helped many companies with such activities and can provide references upon request. 

    Many thanks,

    ------------------------------
    Keith Morel
    VP Regulatory Compliance
    Qserve Group US Inc
    Redwood City, CA
    USA
    keith.morel@qservegroup.com
    +1 551 227 4409
    ------------------------------

    Original Message


  • 5.  RE: Arazy Group

    Posted 22-Aug-2018 10:41
    I would strongly suggest EMERGO at Global Medical Device Consulting  We contract with them for various items.

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 6.  RE: Arazy Group

    Posted 23-Aug-2018 08:50
    I have had a recent miserable experience with Emergo and would absolutely NOT recommend them.
    Original Message


  • 7.  RE: Arazy Group

    Posted 24-Aug-2018 09:16
    For those who are not aware, Emergo doesn't necessarily equal Emergo, so I am not surprised to see such opposing comments as the last couple in this thread. This is because as they grew, Emergo bought up local regulatory consulting groups, the quality of which varies. In my last job (a few years ago so may be different now) I had a fantastic experience with Emergo Japan but an equally bad experience with Emergo Jyton (China). For organizations like this, be sure and ask about performance in specific markets you care about most - very rarely can some single group be "the best" at the entire world.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


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