{"id":4242,"date":"2022-11-09T04:45:00","date_gmt":"2022-11-09T04:45:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4242"},"modified":"2024-07-01T07:00:49","modified_gmt":"2024-07-01T07:00:49","slug":"artificial-intelligence-based-regulatory-intelligence-database","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/artificial-intelligence-based-regulatory-intelligence-database\/","title":{"rendered":"Artificial Intelligence Based Regulatory Intelligence database"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c1c09b85cdffe5dbc8c61f94eb18e148 wp-block-paragraph\">VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health (Food and Cosmetics) and OTC Industries. VISTAAR is most up-to-date compared to any other Intel or data source because it uses smart artificial intelligence methods all throughout. With a unique combination of technology and smart people, you will get your strategy and trusted insights much faster. Over many years, ViSTAAR regulatory intelligence tool has built deep data sets to help users on their Regulatory and Clinical projects.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-861de37fb8a6f322605d9275efe58476 wp-block-paragraph\">ViSTAAR (Regulatory Intelligence Solution), which would be providing the following information:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-59855ad0694fd714947a2c17ebd942e1\">\n<li>The Regulatory information includes Country specific and comparative regulatory requirements reports related to Biopharma, Medical Devices, Digital Health, Diagnostics, and Consumer Health (OTC, Food and Cosmetics) industries. It provides regulatory summaries<\/li>\n\n\n\n<li>Regulatory requirements summary reports for Medical devices, and Diagnostics include reports related to clinical trials, variations, Marketing Authorizations, Materiovigilance, Import\/Export, Quality system, and classification areas.<\/li>\n\n\n\n<li>Regulatory requirement reports for&nbsp;<strong>Consumer Health (Food and cosmetics)&nbsp;<\/strong>consists of Regulatory pathway, labeling, lifecycle, safety applications, and other regulatory framework.<\/li>\n\n\n\n<li>Regulatory requirement reports for&nbsp;<strong>Digital Health<\/strong>&nbsp;consists of Software as a medical device (SaMD), cyber security, medical device interoperability, mobile medical applications, wireless medical devices applications data<\/li>\n\n\n\n<li>Regulatory requirements summary reports for&nbsp;<strong>OTC<\/strong>&nbsp;consists of switching from Rx to OTC or BTC, reverse switching and other regulatory framework data globally<\/li>\n\n\n\n<li>ViSTAAR\u2019s Hunt module provides Health Authority documents from various global and local Agencies<\/li>\n\n\n\n<li>ViSTAAR\u2019s Regbot is an easy, quick, and user-friendly search engine that can be easily integrated into other systems<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-644e5dfbd0d3b73d5f5afa6d90551af2\"><strong>Solution Overview:<\/strong><\/h2>\n\n\n\n<ol>\n<li style=\"color:#000;\"><strong>Global regulatory submission requirements <\/strong><ul>\n<li style=\"color:#000;\">ViSTAAR&#8217;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<\/li>\n<li style=\"color:#000;\">Depending on the granularity based on your needs, you can utilize an intuitive search and interface to review as well as download<\/li>\n<\/ul><\/li>\n<li style=\"color:#000;\">\n<strong>Regulatory updates from Health Authorities &#038; government bodies<\/strong>\n<ul>\n<li style=\"color:#000;\">ViSTAAR&#8217;s HUNT module crawls through global Health agency websites and maintains a repository of regulations and guidance documents which gets updated daily<\/li>\n<li style=\"color:#000;\"><strong>HUNT<\/strong> is built with AI-powered (NLP &#038; ML) search capabilities for true regulatory search and requires no additional tuning<\/li>\n<\/ul>\n<\/li>\n<li style=\"color:#000;\"><strong>Translations<\/strong>\n<ul>\n<li style=\"color:#000;\"><strong>Summarize<\/strong> 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<\/li>\n<li style=\"color:#000;\"><strong>News<\/strong> is powered by Google Translate and data can be translated to Global recognized languages based on selection<\/li>\n<\/ul><\/li>\n<li style=\"color:#000;\"><strong>Advisory committee meeting summaries <\/strong>\n<ul>\n<li style=\"color:#000;\">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<\/li>\n<\/ul>\n<\/li>\n<li style=\"color:#000;\"><strong>Safety updates (PV), Clinical study requirements<\/strong>\n<ul>\n<li style=\"color:#000;\">ViSTAAR&#8217;s <strong>Summarize<\/strong> 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<\/li>\n<li style=\"color:#000;\">ViSTAAR\u2019s <strong>HUNT<\/strong> provides the information for safety and clinical study regulatory updates<\/li>\n<\/ul>\n<\/li>\n<li style=\"color:#000;\"><strong>Quality update (ICH guidelines or other quality guidelines)<\/strong>\n<ul>\n<li style=\"color:#000;\">From ViSTAAR-HUNT, will provide the Quality updates data country by country on pre-approved schedule\/timelines.<\/li>\n<li style=\"color:#000;\">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<\/li>\n<\/ul>\n<\/li>\n<li style=\"color:#000;\"><strong>Digital Health (including Diagnostics and SaMD), and Artificial Intelligence IA<\/strong><\/li>\n<li style=\"color:#000;\">ViSTAAR&#8217;s Summarize provides regulatory requirements information related to Digital Health &#8211; Software as a medical device for various countries and regions<\/li>\n<li style=\"color:#000;\">Switches from Rx to OTC or BTC\n<ul>\n<li style=\"color:#000;\">ViSTAAR\u2019s <strong>HUNT and summarize<\/strong> provides regulatory requirements summary reports and guidance documents\/updates required for switching from Rx to OTC or BTC or reverse switching<\/li>\n<\/ul>\n<\/li>\n<li style=\"color:#000;\">OTC framework\n<ul>\n<li style=\"color:#000;\">ViSTAAR&#8217;s regulatory professional\u2019s 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 <strong>Dossier<\/strong>, etc<\/li>\n<li style=\"color:#000;\">ViSTAAR&#8217;s <strong>Summarize<\/strong> OTC will provide the information related to Clinical trial, Pharmacovigilance, Labelling, Marketing Authorization, Renewal, Variations, CMC, Switching from Rx to OTC and reverse switching<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-a4d9f1a0752aa89d72b47a92c15dfb4b\"><strong>ViSTAAR Benefits:<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-51eed8f3bf2cdf117492850b87f95396 wp-block-paragraph\">ViSTAAR leverages Broader and Deeper Real-World Data to Improve Outcomes and Avoid delays and rejections in the regulatory affairs development Process. It helps Sanofi to anticipate and adapt to regulatory change, provides regulatory requirements along with application forms and many potential regulatory compliance benefits to clients, thereby making them understand<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-85712feb5017fad18d6f83364e182b6c\">\n<li>Requirements of new\/updated regulations<\/li>\n\n\n\n<li>Execute correct processes, policies, and procedures<\/li>\n\n\n\n<li>Manually reviewed regulatory summaries covering advisory, clinical, IRB, market launches, testing standards, submission checklists, fees, labeling, import\/export, marketing, safety\/PV, life cycle requirements, and many more areas in a granular manner<\/li>\n\n\n\n<li>Compare countries or specific areas side-by-side (and download in the format of your preference)<\/li>\n\n\n\n<li>Provides structured and Quality data<\/li>\n<\/ul>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-063c43e30005e18537946fce2c4d9b3a wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><strong><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\">Tags:<\/mark><\/strong> <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/artificial-intelligence\/\" rel=\"tag\">Artificial Intelligence<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/biopharma\/\" rel=\"tag\">BioPharma<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/consumer-health\/\" rel=\"tag\">Consumer Health<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/diagnostics\/\" rel=\"tag\">Diagnostics<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/digital-health\/\" rel=\"tag\">Digital Health<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-devices\/\" rel=\"tag\">Medical Devices<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/otc\/\" rel=\"tag\">OTC<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/regulatory-intelligence\/\" rel=\"tag\">Regulatory Intelligence<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health (Food and Cosmetics) and OTC Industries. VISTAAR is most up-to-date compared to any other Intel or data source because it uses smart artificial intelligence methods all throughout. With a unique combination of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3529,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[643],"tags":[168,317,110,333,331,101,345,166],"class_list":["post-4242","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digital-health","tag-artificial-intelligence","tag-biopharma","tag-consumer-health","tag-diagnostics","tag-digital-health","tag-medical-devices","tag-otc","tag-regulatory-intelligence"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Artificial Intelligence Based Regulatory Intelligence database<\/title>\r\n<meta name=\"description\" content=\"VISTAAR - Artificial Intelligence Based Regulatory Intelligence database\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/artificial-intelligence-based-regulatory-intelligence-database\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Artificial Intelligence Based Regulatory Intelligence database\" \/>\r\n<meta property=\"og:description\" content=\"VISTAAR - 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