Regulatory Open Forum

 View Only

  • 1.  Software/Application for Managing Regulatory Strategy

    Posted 04-May-2023 12:44

    Dear Community, 

    Is anyone aware of a software or application that is designed for the management of regulatory strategies for compound development programs?  

    Thanks,
    Monique



    ------------------------------
    Monique Franc
    Scientific Director
    North America Regulatory Lead - Neuroscience
    Janssen
    NJ, USA
    ------------------------------


  • 2.  RE: Software/Application for Managing Regulatory Strategy

    Posted 04-May-2023 14:40

    Hi Monica,
    Last year, I attended a demo session with GreenlightGuru and they had a module for 510k and other submissions. I would reach out to them and request a demo.

    -Carol



    ------------------------------
    Carol
    ------------------------------

    Original Message


  • 3.  RE: Software/Application for Managing Regulatory Strategy

    Posted 05-May-2023 02:37

    Hi,
    Not related to compound development but medtech for other open forum visitors: The Entries platform by Lean Entries does not manage regulatory strategies but generates a personalized strategy based on the learning experience it provides. Entries is targeted to early stage research-to-business teams and startups and it has served over 200 of such teams here in the Nordics. This may be worth to look at if you're in medtech https://www.leanentries.com/

    Anja 



    ------------------------------
    Anja Kontio
    Quality and Regulatory Affairs Manager
    Finland
    ------------------------------

    Original Message


  • 4.  RE: Software/Application for Managing Regulatory Strategy

    Posted 05-May-2023 07:25

    Dear Monique,
    My company is working with VivPro, which is an AI driven system that allows the user to query regulatory documentation (summaries, labels, etc.) from US and EU. They have recently added Canada as well.  There are many other features of the system that we find useful, for example a label side by side comparison for US and EU and between the two regions.  The user can also query ct.gov through the VivPro platform.  Start with their website https://vivpro.ai/

    Best,
    Carol B.



    ------------------------------
    Carol Stinson PhD
    Director,US Hub Leader
    Gaithersburg MD
    United States
    ------------------------------

    Original Message


  • 5.  RE: Software/Application for Managing Regulatory Strategy

    Posted 10-May-2023 15:15

    Hi monique,
    Veeva Vault RIM, Montrium Regulatory Information Management (RIM), Aris Global Regulatory Information Management (RIM), Ennov Regulatory are some of the cloud-based solutions that include capabilities for regulatory strategy, submission and compliance.



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 6.  RE: Software/Application for Managing Regulatory Strategy

    Posted 11-May-2023 08:27

    Hi, 
    Our company developed systems internally. However this takes years. For a system "ready for purchase" I have found that RAPs Convergence has excellent venders and demos. This year Convergence is in early October.
    You can also look at venders from 2022.




    ------------------------------
    Emily Nesbitt RAC
    Director, Regulatory Affairs
    Cincinnati OH
    United States
    ------------------------------

    Original Message


Related Content