Regulatory Intelligence, Monitoring and Risk Analysis Tool

Global Clinical and Post Market Safety and Pharmacovigilance Services for Pharmaceutical and Biotech Industry

Services We Offer

Regulatory Intelligence, Monitoring and Risk Analysis Tool

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 regulatory intelligence software tool, comprehensively covers all applicable regulatory guidelines from health authorities and tracks regulatory updates in real time.

QuriousRI – Highlights

AI-Enabled Global Regulatory Tracking
In-Country, Experienced Regulatory Expertd
Expert Analysis of Updates & Risk Assessment
Customized, Actionable Insights
Wide Industry and Therapy Area Coverage
Easy Setup and Personalized Alerts

Key Features

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

Receive email alerts on daily, weekly, fortnightly or monthly basis.

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

Why Artixio For Pharmacovigilance Services?

Successful Case Studies Pharmacovigilance and Safety Monitoring for 500+ products
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expertise in 70+ markets with 15-35 years of experience
Proven Experience in End to End Product Value Chain from Clinical Development to Post Market
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global pharmacoviglance services supported by regulatory intelligence platform, Dvarka
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Safety functions

FAQs

1. How can QuriousRI 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?

Simply write to info@artixio.com and our team will assist you with the process.

3. How do you keep track of regulatory updates from health authorities?

Artixio leverages our in-house artificial intelligence engineering, data sciences team track global updates in real time automatically. Our regulatory experts then review the updates to prepare a summary and perform further Risk Analysis.