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  • 1.  Regulatory Competitive Intelligence Programs/Databases

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jun-2023 09:34
    This message was posted by a user wishing to remain anonymous

    Hello all,

    My company is interested in finding a program that can do regulatory intelligence screening, specifically in regard to competitive intelligence so we can monitor what our competitors are doing as part of their regulatory strategy.

    I've heard of Tarius and Cortellis, but does anybody have any more recommendations?

    Thank you!



  • 2.  RE: Regulatory Competitive Intelligence Programs/Databases

    Posted 29-Jun-2023 08:34

    Dear Colleague,

    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.  They have also recently added CHAT-GPT capabilities.  Start with their website https://vivpro.ai/

    Carol S.



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


  • 3.  RE: Regulatory Competitive Intelligence Programs/Databases

    Posted 30-Jun-2023 00:28
    Edited by Ivan Perez Chamorro 30-Jun-2023 00:29

    Hello,

    we (MedBoard) do regulatory intelligence screening here among many other regulatory resources for 225+ countries and competitive analysis/databases with 50k+ manufacturers integrated information, feel free to get in touch with us at www.medboard.com 

    we will be very happy to help,

    Many thanks!



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    Ivan Perez Chamorro
    United Kingdom
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    Original Message


  • 4.  RE: Regulatory Competitive Intelligence Programs/Databases

    Posted 30-Jun-2023 02:23

    Check out https://tinyurl.com/bdhr8adx 

    Link includes a sample side by side comparison search between US FDA/Gov search sites and SmartSearch+ on FDA.Gov published PDF Guidance and 21 CFRs with medical devices, biologics and drugs.

    A former US FDA Deputy Directors wished he had back during his stint with the US FDA and a leading legal/life sciences advisory company is using SmartSearch+  now integrated with OpenAI ChatGPT-3.5 Generative LLM for their due diligence on DSCSA before it becomes mandatory November 2023.

    Try searching at FDA.Gov for DSCSA (Drug Supply Chain Security Act) and you''' clearly see the difference after viewing these attachment samples. Attachment includes a full-text search with ChatGPT-3.5 prompt/reply to assist with search keyword hints against ACTUAL FDA contents, no AI/ML bias with SmartSearch+, i.e. if FDA.Gov publishes it, you'll find it.

    Ram Balani

    eSTARHelper LLC 



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    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/3jbjcd7v
    on US FDA eSTAR for 510(K)
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    Attachment(s)

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    Page4-DSCSA NEAR exemptStar.pdf   1.01 MB 1 version
    pdf
    Page1-DSCSA NEAR exemptStar.pdf   1.02 MB 1 version
    Original Message


  • 5.  RE: Regulatory Competitive Intelligence Programs/Databases

    Posted 02-Jul-2023 13:53

    Are you looking to monitor trials and approvals or other items such as evolving regulations and guidance. Is this for drugs/biologics or devices? Do you want a global platform or a focus on a specific region. Do you need everyone in the company to have access or a select group. Do you want single-sign on or password needed.

    I suggest having demos of multiple products to ensure it is the right fit for you. I have been in the policy and intelligence space since 2006 and have used the ones you mentioned as well as BioMed Tracker and ADIS Insight, which are competitive intelligence tools. Specific for oncology there is RxTrospect. We have recently been using a platform developed by Cedience. The right tool is really dependent on your specific needs. 



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    Linda Bowen MSC, RAC, FRAPS
    Past Chair, NJ NY RAPS Chapter]
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    Original Message


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