Regulatory Open Forum

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  • 1.  Urgent SLP Help Needed

    Posted 25-Apr-2023 12:48

    Hi,

    I am looking for someone who can quickly help our company to fix SPL errors for our drug listing submission
    Please contact me if you can help or have a contact.

    Thank you



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    Valeria Shkuratova
    Canada
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  • 2.  RE: Urgent SLP Help Needed

    Posted 26-Apr-2023 11:00

    We use Reed Tech, generally helpful and quick to respond. https://www.reedtech.com/contact/



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    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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  • 3.  RE: Urgent SLP Help Needed

    Posted 26-Apr-2023 12:44
    We can assist as well.We do new drug establishments, drug product listing registrations,also a Microsoft Partner. Can you elaborate a bit on what the SPL refers to Valeria?

    That aside and at your convenience,allow me to share our SmartSearch+ introduction here,
    i.e. a video recording dueling banjo,side by side search between FDA.gov search vs. SmartSearch+ now also integrated with ChatGPT-3 to merely assist with keyword hints so one can search FDA.gov PDF Guidance and 21 CFRs on medical devices,biologics and drugs.
    https://tinyurl.com/2s4747hp
    Runs on any device browser based mobile,tablet or laptops.