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QuriousRI Regulatory Intelligence, Monitoring and Risk Analysis Tool
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QuriousRI — The Leading Regulatory Intelligence Platform
Access regulatory guidelines, guidance in key markets worldwide to compliment your ongoing regulatory affairs department for new product clinical development, product registration, product launch, pricing and reimbursement and post approval lifecycle maintenance. QuriousRI, Artixio’s AI powered regulatory intelligence software tool, comprehensively covers all applicable regulatory guidelines from health authorities and tracks regulatory updates in real time.
QuriousRI Regulatory Intelligence Tool Highlights
- AI-Enabled Global Regulatory Tracking
- In-Country, Experienced Regulatory Expert
- Expert Analysis of Updates & Risk Assessment
- Customized, Actionable Insights
- Wide Industry and Therapy Area Coverage
- Easy Setup and Personalized Alerts
Key Features of our Regulatory Intelligence Tool
| Step | Feature | Description |
|---|---|---|
| 1 | Engage All Stakeholders | Bring all key stakeholders across teams onto one unified platform. |
| 2 | Setup Tracking Dashboard | Configure dashboards by Country, Therapy Area, Key Functions, and Products of Interest. |
| 3 | Notification Frequency | Select how often you want updates and receive email alerts accordingly. |
| 4 | Review Updates | Get summarized update headlines and brief reviews prepared by Artixio’s expert team. |
| 5 | Risk Impact Analysis | Analyze potential impacts of new updates on your products, portfolio, or documentation across markets. |
Set Your Frequency of Updates
Dashboards
- Review Historical Updates and Related Guidelines
- Analytics Dashboard covering Regions, Countries, Update Types, Functions Impacted and more
- Assess Regulatory Risks based on Historical and New Updates to plan for potential future risk mitigation plans
Risk Impact Analysis
Assess Products and Licenses that may be at Risk due to Changing Regulations
Our Risk Analysis module covers deep-analysis of regulatory update on products and documents across product categories, therapy areas and regulatory functions, led by our in-country experienced team of Regulatory specialists.
Identify Key Functions That can be potentially at Risk including, Labeling, Artwork and Packaging, Patient Communication, Manufacturing, Quality, Clinical, Safety, Import and Customs, Administrative, Environment and other areas.
Risk Scoring based on Scale of the Risk across Product Classes, Procedure and Process Level, Functional areas and document. Risk assessment with variable degree of impacts, including,- No impact
- Administrative Information, Internal Changes Possible
- Minor administrative changes possibly leading to some Health Authority (HA) submissions
- Major technical/Admin changes leading to Health Authority (HA) submissions or Change in Regulatory Strategy
Wide Industry and Therapy Areas Coverage
- Pharmaceuticals, Biologics, Biosimilars, Cell and Gene Therapy, Radiopharmaceuticals, Cosmetics, Supplements, Nutraceuticals and Food.
- Oncology, Rare Diseases, Cardiovascular, Metabolic, Neurology, Infectious Diseases, Inflammation, Pain, Allergy and others.
Integrated Regulatory Strategy, Planning and Gap Analysis – QuriousRI-GP
Our tracking and monitoring platform is integrated with the QuriousRI-GP, a one of its kind Regulatory Strategy, Planning and Gap Analysis simulation platform to fast track your strategy and planning process for key markets worldwide.
Expert Regulatory Team at Speed Dial
Artixio’s regulatory experts are based in key markets worldwide bringing decades of experience working on successful product approvals (new chemical entities, generics, biologics, biosimilars, radiopharmaceuticals, cell and gene therapy and others). You can access our team for specific questions you may have related to the regulations in a country or a new regulatory update.
FAQs
1. How can QuriousRI software help my team with regulatory intelligence?
QuriousRI helps regulatory teams access regulations, guidelines from health authorities worldwide across product categories. It also helps tracking latest updates coupled with expert written summaries to stay ahead of new changes that may potentially impact their products (under development or marketed) in global markets. QuriousRI also offers deep-dive impact analysis on therapy areas, products or processes in general that can help regulatory teams assess the impact and potential risk of new regulatory update on their portfolio.
2. How can I access QuriousRI regulatory intelligence tool?
3. How do you keep track of regulatory updates from health authorities?
Still Have Questions ?
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Regulatory Affairs Across Multiple Countries
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