QuriousRI-GP – Regulatory Strategy and Planning Tool

Services We Offer

QuriousRI-GP – Leading Regulatory Strategy & Planning Platform

Simulate diverse and complex regulatory scenarios across leading markets worldwide for your pharmaceutical, biologics, medical devices, radipharmceutical and combination products. Leverage Artixio’s regulatory intelligence database, QuriousRI, latest regulatory updates, analysis of regulatory pathways in key markets for all applications (new drugs, abbreviated pathways, lifecycle, paediatric, orphan drug), documentation requirements based on reference drugs / predicate products approved in the target markets. Build your regulatory roadmap seamlessly with Artixio expert driven regulatory insights.

Visualize Your Regulatory Strategy

Verify Novelty	Analyse competitor drugs approved in the target markets to establish novelty
Define Pathway	Assess applicable pathways based on local regulations and reference / predicate products
Assess Requirements	Deep dive into regulatory requirements following the pathway including local testing, characterization and stability requirements
Assess Documentation	Surf the comprehensive list of documents required per regulatory requirements including those requiring translation and legalization
Compare	Streamline your global strategy comparing pathways and documentation required across multiple countries
Mitigate Gaps	Use your approved or existing dossier against target market requirements to find gaps. Leverage Artixio’s insights for mitigation of gaps

Global Product Lifecycle and Portfolio Management Dashboard

Set up your portfolio of products across countries, therapy areas, formulations, strengths, routes of administration, new registrations, lifecycle maintenance (variations, renewals, withdrawals, recalls, line extensions) in a global dashboard. Track their status and plan for continued compliance and supply chain management.

Regulator Intelligence Agents

Leverage RI-Agents trained on set of data to find structured answers to your regulatory queries. The agents are trained on global regulatory guidelines coupled with Artixio’s experience in successfully managing compliance for life sciences products worldwide.

Chat with documents to prepare summaries, answer specific questions and augment your regulatory strategy with key insights.

Get in touch with our team to explore QuiriousRI-GP and start your regulatory strategy and planning journey with Artixio.

Should you wish to develop custom solutions for your specific needs, our in house team of artificial intelligence engineers and data scientists can help you build one, Fast and Efficient.

FAQs

What are the features of QuriousRI-GP?

QuriousRI-GP offers end to end life sciences (pharma, devices, biologics etc.) product lifecycle management strategy and planning solutions to prepare submission documents for health authorities worldwide. It also helps tracking the products status worldwide from planning to gap analysis, dossier preparation, submission, approval and post approval lifecycle maintenance. It offers assessment of reference and predicate products in the markets, applicable regulatory pathways, regulatory requirements in target countries, documentation requirements, comparison of multiple countries and perform gap analysis of documents.

Which countries are covered in the QuriousRI-GP?

All the key markets across APAC, LATAM are covered in the tool currently such as Thailand, Malaysia, China, Japan, Hong Kong, Brazil, Mexico and others.

How does the regulatory intelligence work in the tool?

QuiriousRI-GP’s underlying analytics is based in Artixio Team’s decades of regulatory experience in successfully registering new complex products and maintaining compliance. In addition, integration of guidelines, and updates coupled with Artixio’s case studies and regulatory intelligence database helps build the reliable decision support engine for the platform.