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.

ViSTAAR (Regulatory Intelligence Solution), which would be providing the following information:

• 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
• 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.
• Regulatory requirement reports for Consumer Health (Food and cosmetics) consists of Regulatory pathway, labeling, lifecycle, safety applications, and other regulatory framework.
• Regulatory requirement reports for Digital Health consists of Software as a medical device (SaMD), cyber security, medical device interoperability, mobile medical applications, wireless medical devices applications data
• Regulatory requirements summary reports for OTC consists of switching from Rx to OTC or BTC, reverse switching and other regulatory framework data globally
• ViSTAAR’s Hunt module provides Health Authority documents from various global and local Agencies
• ViSTAAR’s Regbot is an easy, quick, and user-friendly search engine that can be easily integrated into other systems

Solution Overview:

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

ViSTAAR Benefits:

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

• Requirements of new/updated regulations
• Execute correct processes, policies, and procedures
• 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
• Compare countries or specific areas side-by-side (and download in the format of your preference)
• Provides structured and Quality data