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Artificial Intelligence Based Regulatory Intelligence database

  1. Global regulatory submission requirements
    • ViSTAAR’s Summarize is a unique Regulatory Intelligence database that uses advanced technology providing regulatory submission requirements summary reports thereby enabling Medical Devices, Digital Health, Consumer Health (OTC, Food and Cosmetics) companies to understand and efficiently manage the varied regulatory requirements to plan/manage their products in various markets
    • Depending on the granularity based on your needs, you can utilize an intuitive search and interface to review as well as download
  2. Regulatory updates from Health Authorities & government bodies
    • ViSTAAR’s HUNT module crawls through global Health agency websites and maintains a repository of regulations and guidance documents which gets updated daily
    • HUNT is built with AI-powered (NLP & ML) search capabilities for true regulatory search and requires no additional tuning
  3. Translations
    • Summarize provides translation for all country languages regulatory requirements data of various Business Areas such as clinical trials, market authorization, CMC, etc., related to Biopharma, Medical Devices, Digital Health, Consumer Health (OTC, Food and cosmetics) for various countries and regions
    • News is powered by Google Translate and data can be translated to Global recognized languages based on selection
  4. Advisory committee meeting summaries
    • ViSTAAR provides summaries of tasks, membership, and meetings of advisory committees related to OTC, Medical Devices, Food Supplements, and Cosmetics industries for all countries along with FDA and EMEA
  5. Safety updates (PV), Clinical study requirements
    • ViSTAAR’s Summarize provides the Clinical safety and post marketing safety related to Biopharma, Medical Devices, Digital health, Consumer Health (OTC, Food and cosmetics) for various countries and regions through simple search
    • ViSTAAR’s HUNT provides the information for safety and clinical study regulatory updates
  6. Quality update (ICH guidelines or other quality guidelines)
    • From ViSTAAR-HUNT, will provide the Quality updates data country by country on pre-approved schedule/timelines.
    • It provides the latest updates related to ICH and other quality guidelines. It provides information for any changes in the latest update with the Date, its status, and a summary of the update
  7. Digital Health (including Diagnostics and SaMD), and Artificial Intelligence IA
  8. ViSTAAR’s Summarize provides regulatory requirements information related to Digital Health – Software as a medical device for various countries and regions
  9. Switches from Rx to OTC or BTC
    • ViSTAAR’s HUNT and summarize provides regulatory requirements summary reports and guidance documents/updates required for switching from Rx to OTC or BTC or reverse switching
  10. OTC framework
    • ViSTAAR’s regulatory professional’s team will provide intelligence reports by analyzing the updated or new guidance documents and customize the data related to specific data points thereby reducing your time to go through the entire guidance document for one specific piece of information such as Dossier, etc
    • ViSTAAR’s Summarize OTC will provide the information related to Clinical trial, Pharmacovigilance, Labelling, Marketing Authorization, Renewal, Variations, CMC, Switching from Rx to OTC and reverse switching