freya.RTQ

Tackle Regulatory Queries

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

  • 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 & 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. 

  • 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.

Built for Queries. Backed by Intelligence.

freya.RTQ doesn't just help you respond - it helps you pre-empt, personalize, and perfect every interaction with regulatory authorities.

How freya.RTQ Stacks Up

Feature

  • Query Prediction
  • RTQ Repository
  • Smart Response Drafting
  • Global Smart Search
  • Contextual Linking
  • Real-Time Collaboration
  • Analytics & Trends
  • Regulation Insights
  • Knowledge Continuity
  • Speed & Accuracy

  • AI-first insights to anticipate likely queries before submission
  • Centralized, searchable, and filterable across products, markets, and query types
  • AI-assisted drafts based on past responses, product data, and regulations
  • Search across RTQs + curated regulations by region, topic, or keyword
  • Automatically links similar past queries and relevant regulations
  • Role-based access for affiliates and global teams; track comments, status, and deadlines
  • Tracks most frequent query topics, response times, and authority behavior
  • freya-curated regulation summaries tied directly to query topics
  • Institutional knowledge preserved even when teams change
  • Faster, context-rich responses backed by historical intelligence

Others

  • No forecasting; only reactive tracking
  • Fragmented email chains or static spreadsheets
  • Manual drafting, from scratch every time
  • Limited keyword search or file-based lookup
  • No relational insights; manual effort needed
  • Shared folders or static documents
  • No trend insights or query intelligence
  • No regulatory context or linkage
  • High risk of knowledge loss with team turnover
  • Slower response cycles, higher error risk