freya.RTQ:
AI-First Insights to Tackle Regulatory Queries Smarter and Faster
When it comes to regulatory queries, speed and accuracy aren’t optional - they’re everything.
freya.RTQ empowers teams to anticipate, manage, and respond to Health Authority (HA) queries with confidence, context, and consistency. Whether you’re preparing a new submission or addressing an unexpected question, Freya’s AI ensures you’re never starting from scratch.
Real-World Use Cases
Medicinal Products
- Pre-Submission Query Forecasting
Anticipate HA queries based on therapeutic area trends and historical application data. - Cross-Market RTQ Repository
Access past queries across countries to align dossier strategies and reduce review cycles. - AI-Backed Technical Drafting
Respond to complex queries with curated regulatory references and precedent-based content. - Agency-Specific Response Intelligence
Tailor answers based on known focus areas of FDA, EMA, PMDA, and other regulators.
Medical Devices
- Design & Labelling Query Tracking
Manage historical HA questions related to device specs, labels, and packaging. - Notified Body Communication Archive
Centralize Q&A logs to accelerate EU MDR/IVDR compliance and audit readiness. - UDI & SSCP Response Support
Reuse prior responses and references for faster resolution of UDI and performance-related queries. - CE Recertification Acceleration
Identify recurring RTQ themes to speed up recertification and re-entry submissions.
Consumer
- Claims & Label Query Repository
Track objections to marketing claims and visuals, especially in borderline product categories. - Regional Sensitivity Alerts
Flag common triggers in strict regions like GCC and ANZ to preempt HA concerns. - Product-Specific Query Management
Organize query history by SKU, dosage form, or brand to maintain consistency. - Fast Compliance Checks for Updates
Auto-draft responses for formulation or promotion changes using AI-powered support.
Spotlight Features
Ask Freya Anything
Use conversational AI to find past queries, draft responses, and access regulatory history in seconds.
RTQ Repository
Access every query and response in one place - searchable by product, market, keyword, or category.
Global Smart Search
Search across regulatory topics and countries with linked documents, summarized regulations, and source references.
Draft Builder with Context
Auto-generate responses with references to past submissions for consistent, compliant communications.
Alerts & Regulatory Deadlines
Stay on top of follow-ups with automated reminders and reduce risk of missed HA expectations.
Cross-Team Visibility
Enable real-time access for affiliates, country teams, and global regulatory leads—keeping everyone aligned.
Knowledge Continuity
Capture institutional knowledge across teams - making every past query a learning asset for the future.
Why Freya.RTQ Is the Right Choice
Respond with confidence using AI-powered drafting built on real-world regulatory precedent and HA behavior.
Understand the context behind every query with linked regulations and historical response patterns.
Track key performance metrics like average response time and common authority-specific issues.
Benefit from AI trained specifically on regulatory use cases—not generic language models.
How freya.RTQ Stacks Up?
| Feature | freya.RTQ | Traditional Systems |
|---|---|---|
| Query Prediction | AI-powered insights to anticipate likely queries before submission | No forecasting; only reactive tracking |
| RTQ Repository | Centralized, searchable, and filterable across products, markets, and query types | Fragmented email chains or static spreadsheets |
| Smart Response Drafting | AI-assisted drafts based on past responses, product data, and regulations | Manual drafting from scratch every time |
| Global Smart Search | Search across RTQs + curated regulations by region, topic, or keyword | Limited keyword search or file-based lookup |
| Contextual Linking | Automatically links similar past queries and relevant regulations | No relational insights; manual effort needed |
| Real-Time Collaboration | Role-based access for affiliates and global teams; track comments, status, and deadlines | Shared folders or static documents |
| Analytics & Trends | Tracks most frequent query topics, response times, and authority behavior | No trend insights or query intelligence |
| Regulation Insights | Freya-curated regulation summaries tied directly to query topics | No regulatory context or linkage |
| Knowledge Continuity | Institutional knowledge preserved even when teams change | High risk of knowledge loss with team turnover |
| Speed & Accuracy | Faster, context-rich responses backed by historical intelligence | Slower response cycles, higher error risk |