freya.RTQ

freya.RTQ: AI-First Insights to Tackle Regulatory Queries Smarter and Faster Operations

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 fusion ensures you’re never starting from scratch.

Real-World Use Cases

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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.
02 / 03
Medical Devices
Design & Labeling 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.
03 / 03
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 pre-empt 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

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.

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 and compliant communications.

Why freya.RTQ Is the Right Choice

Respond with confidence using AI-first 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		Traditional Systems
Query Prediction	Yes	No
Centralized RTQ Repository	Yes	No
AI-Assisted Response Drafting	Yes	No
Global Smart Search	Yes	No
Contextual Auto-linking	Yes	No
Real-Time Collaboration	Yes	No
Analytics & Trends	Yes	No
Contextual Regulation Insights with AI	Yes	No
Knowledge Continuity	Yes	No
Speed & Accuracy	Yes	No