VISTAAR provides data and intelligence in areas of Global Regulatory, Clinical, and Compliance Requirements to all sizes of companies to help product introductions and maintain ongoing global compliance.
VISTAAR caters to the following industries:
BioPharma
You Need Authoritative and most up-to-date regulatory requirements that you can depend on; You need to see what clinical activity is happening in different countries in your therapeutic areas and what products are being marketed that competes with yours.
How VISTAAR can help?
VISTAAR utilizes technology (enabled by AI) and our global subject matter experts to align our Broader and Deeper datasets to your needs (in the form of reports, searches, alerts, and monitoring). You get:
VISTAAR Expertise
- Regulatory requirements for Drugs, Biologics, OTC, Generics, Pediatric, and Orphan disease pathways.
- 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).
- Search marketed products and their Labels from Canada, US, UK, and EU.
- 1.2 Million Global document repository of health authorities’ regulations and guidance, updated daily and provided to you with AI-enabled search for faster and better matches.
- Global clinical trials gathered from global registries for you to see all clinical activity.
- Integrate with any of your existing tools to get this “knowledge” into your daily systems.
Medical Devices
Unlike BioPharma, for Device manufacturers requirements of Regulatory, Quality and Compliance are of equal weightage. In order to make product introduction or product changes, all these are to be assessed at the same time.
How VISTAAR can Help?
VISTAAR utilizes technology (enabled by AI) and our global subject matter experts to align our Broader and Deeper datasets to your needs (in the form of reports, searches, alerts, and monitoring). You get:
VISTAAR Expertise
- Regulatory requirements for Devices, Diagnostics, Digital Health, SaMD, and Combinational products.
- Manually reviewed regulatory summaries covering clinical, technical, QMS/Quality, market launches, testing standards, submission checklists, fees, labeling, import/export, marketing, safety/Vigilance, 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).
- Compliance requirements (ROHS, REACH, etc).
- Global up-to-date technical standards and subscribe to alerts.
- 1.2 Million Global document repository of health authorities’ regulations and guidance, updated daily and provided to you with AI-enabled search for faster and better matches.
- Global clinical trials gathered from global registries for you to see all clinical activity.
Consumer Health
Growing consumer concerns over claims of the products and long term health implications of certain ingredients have pushed Health Authorities to implement stringent regulations to control and monitor the quality of products. This means tighter control over research, manufacturing, quality control, labeling, storage, and distribution which has traditionally been a practice, although more complex, in the pharmaceutical segment.
How VISTAAR can Help?
VISTAAR offers structured and comprehensive regulatory requirements summaries for consumer healthcare products spanning Food, healthcare, OTC, Cosmetics across countries. Also included is ingredient specific maximum permitted levels and restricted lists
VISTAAR Expertise
- Precompiled and manually reviewed regulatory requirements such as registration dossier, claims, list of ingredients prohibited, and ingredients maximum permitted levels.
- Compare and download more than 15+ countries on different parameters side-by-side.
- Tracks changes in regulations and guidelines.
Cosmetics
Although regulations applicable to cosmetic products are increasingly being harmonized to reduce international barriers to trade, there are still significant differences to take into account when marketing cosmetics in markets around the world.
How VISTAAR can Help?
To get a better handle on cosmetic regulations, VISTAAR provides structured and comprehensive regulatory requirements summaries for cosmetic products across countries along with the ingredient specific maximum permitted levels and restricted list.
VISTAAR Expertise
- Precompiled and manually reviewed regulatory requirements like registration dossier, claims, imports, list of ingredients prohibited, and ingredients maximum permitted levels.
- Hundreds of updates added to our repository of Million+ documents.
- Search data to find ingredients lists and minimum/maximum permitted levels.
Digital Health
Global Regulatory agencies want to know how you are using Software in your products, what role it’s playing and how HCP / end users can rely on it. While some countries have formed good framework to regulate these, other countries are still at starting stages and some created guidance/regulations that are not well thought out. All these aspects impact companies on their global plans of having their products available in different markets while complying with local regulations.
How VISTAAR can Help?
VISTAAR analyzes all global regulations pertaining to Software as Device/Diagnostic, Software used in Devices, IOT and other categories and makes this information available to you in the form of reports, searches, alerts, and monitoring).
VISTAAR Expertise
- Precompiled and manually reviewed regulatory requirements such as registration requirements, Testing standards, cyber security rules, data confidentiality, privacy and other data points.
- Compare country details and download different parameters side-by-side.
- Tracks changes in regulations and guidelines and send alerts.
Why VISTAAR?
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- Deep Datasets
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- Best Practices
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- AI Enabled
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- Cost Effective