freya.intelligence

Empower Your Regulatory Decisions

Visit Our Website

freya.intelligence Empower Your 
Regulatory Decisions

Our flagship AI-first Regulatory Intelligence platform that simplifies compliance across 200+ global markets. Powered by automation, machine learning, and expert-curated insights, it offers a centralized, continuously updated repository of over 100k+ verified regulations. With real time updates, multilingual search, an AI chatbot, and analytics dashboards, freya reduces manual effort and enables faster, smarter regulatory outcomes for life sciences teams worldwide.

Real-World Use Cases

  • Medicinal Products

    Instant Clarity on EMA Biosimilar MAA Requirements

    A Regulatory Affairs Manager preparing a biosimilar MAA for the EU can simply ask freya, “What are the requirements for submitting a marketing authorization application for a biosimilar medicine in the EU?” freya instantly provides a structured, expert-verified answer with EMA-specific pathways and reference links, saving hours of manual research and enabling faster, aligned submission planning.

    Latest Vaccine Regulations from China, Filtered in Seconds

    A global regulatory strategist can leverage the freya.regulations repository to quickly identify the latest vaccine-related updates from China by applying advanced filters- market (China), product type (Vaccines), and document date (last 3 months). The centralized database instantly surfaces a curated list of latest NMPA guidelines, updated lot release procedures, and revised safety surveillance timelines, each with summaries, source links, and download options, empowering faster local alignment and regulatory readiness.

    Proactively Updated on Regulatory Shifts Across Markets

    To periodically monitor global changes impacting biologics, generics, and vaccines, a Regulatory Intelligence Lead can set up custom bi-monthly newsletters using freya.Alerts. By setting filters for regions (US, EU, Asia-Pacific) and document types (PV, Labelling, QMS), they receive summarized, SME-reviewed updates along with AI-generated insights, release dates, and source links, enabling faster alignment and proactive compliance across markets.

    Regulatory Trend Insights for Biopharma Pipeline Strategy

    To identify quarterly regulatory shifts impacting pipeline planning, compliance risks, and resource allocation, a Regulatory Affairs Director can refer freya.Dashboards housing custom, interactive, real-time visualizations built from data across 1,800+ global health authorities. The dashboards reveal regulatory activity by market (US, EU, Asia, LATAM), product category spikes (vaccines, biosimilars, generics), topic breakdowns (PV, labeling, GMP) and timeline trends, empowering leadership to make faster, data-driven decisions on pipeline and compliance strategy.

    Accelerated HA Query Responses for GMP & Submission Readiness

    To handle rising complexity in responding to health authority queries, a global regulatory submission team turns to freya.RTQ. The platform centralizes historic and ongoing RTQs into a structured, searchable repository powered by AI for rapid retrieval and first-draft response creation. They can simply ask “I’ve been asked to provide a risk assessment for nitrosamines during a GMP inspection for Losartan. Can you help me draft a response?” and the system pulls context from historic responses, applies AI-assisted drafting, and suggests a consistent, compliant answer, reducing turnaround time, improving quality, and revealing recurring agency patterns, streamlining every step from intake to submission.

  • Medical Devices

    Instant EU MDR Guidance for Class III Device Submissions

    Medtech regulatory teams can ask, “What are the EU MDR requirements for CE-marking a Class III medical device?” and get an immediate, structured response from freya covering Annex II & III documentation, clinical evaluation needs, Notified Body steps, and PMS/PMCF obligations. With links to MDR and MDCG sources, teams align faster, reduce Notified Body delays, and streamline submission planning.

    FDA Guidance Access for SaMD Submission Readiness

    Digital health teams can use freya.Regulations to filter recent FDA updates on Software as a Medical Device by market, product type, and date range. In seconds, they retrieve targeted documents on cybersecurity, clinical evaluation, and device software functions. With direct access to the latest guidance, teams align submission plans, minimize regulatory queries, and accelerate time to market.

    Custom Alerts for Global Medical Device Compliance

    Regulatory teams managing diagnostics, surgical tools, and wearables can configure freya.Alerts to receive tailored newsletters on evolving requirements across US, EU, China, and Japan. By filtering for product class and topics like UDI, labeling, and clinical evaluation, teams get weekly updates with summaries and source links enabling faster action, reduced compliance risk, and better coordination across global markets.

    Unified Standards Monitoring for Global Device Compliance

    Medical device teams can refer the Standards Dashboard to track ISO, IEC, ASTM, and national standards across markets in one centralized view. With filters by standard number, topic, and issuing body, plus AI-generated summaries and direct purchase links, teams stay updated on changes in areas like sterilization, software, and risk management, reducing manual tracking and ensuring timely updates to design a QMS documentation.

    Efficient Query Management for MDR-Ready Device Teams

    Medical device teams can leverage freya.RTQ to log, search, and respond to Notified Body and Health Authority queries with consistency and speed. AI-powered search retrieves past responses, while automated workflows route tasks and approvals. Dashboards track recurring issues reducing turnaround time by 40%, standardizing communication, and helping pre-empt common NB concerns in future MDR submissions.

  • Consumer

    Instant Clarity on Labels, Claims & Packaging

    OTC regulatory teams can ask region-specific questions like “What are the warning label requirements in the US for cough syrups?” or queries on packaging requirements, label claims, or classification rules and get freya-generated, expert-verified answers. With access to 100k+ regulations across 200+ markets, freya delivers precise, reference-backed insights in seconds eliminating manual searches and enabling faster, more confident compliance decisions.

    Market-Specific Claim Compliance for Confident Labelling

    OTC Product teams use interactive claims dashboards to validate and compare health claims like “boosts immunity” or “relieves headaches” across multiple markets. It delivers market-wise claim classification (therapeutic, functional, structure-function), permission status (allowed, restricted, conditional), and labelling instructions down to font, placement, and warning text. Teams can also receive RDA-based compliance checks and source links, helping accelerate launches, reduce regulatory risk, and ensure globally consistent, compliant messaging.

    Stay Audit-Ready with Real-Time Global Labelling Alerts

    Consumer health teams can receive timely regulatory alerts on label changes, dosage limits, and claim updates tailored by product type, market, and category. Whether it’s a revised allergen warning in the EU or new font size rules in LATAM, get curated updates straight to your inbox with source links and effective dates with freya.Alerts.

    Filtered EU Compliance Updates for Skincare Reformulations

    Cosmetics teams can filter EU-specific updates on ingredients, allergens, and documentation using freya.Regulations. By narrowing by region, product type, and focus area, they instantly access SCCS opinions, Annex III allergen rules, and CPSR guidance with expert summaries, source links, and grouped documents. This enables faster reformulation decisions, early packaging updates, and full compliance in under 30 minutes.

    Multi-SKU Impact Assessment for Global OTC Compliance

    When a GRASE update affects multiple SKUs, consumer health teams can use the Impact Assessment module to instantly identify impacted products, outdated label language, and region-specific actions. With trigger analysis, stakeholder assignments, and real-time dashboards, teams align R&D, labelling, and compliance, enabling pre-emptive updates, cross-functional coordination, and leadership-ready impact summaries within 24 hours.

Spotlight Features

Regulatory Data at Your Fingertips

Instantly access a curated repository of 100k+ verified regulations across 200+ global markets.

Stay current with real-time updates powered by 2,300+ automation bots, capturing data from 1,500+ regulatory authorities worldwide.

AI-Powered Assistance

Leverage freya, a domain-trained chatbot that delivers accurate, referenceable, and expert-verified insights.

Ask questions and get precise answers to complex regulatory queries in seconds-eliminating manual research and guesswork.

Smart Content Management

Break language barriers with multilingual document translations and contextual document chat in 60+ languages.

Use AI-driven document summarization and intelligent navigation to understand lengthy regulatory texts effortlessly.

Enterprise-Grade Security

Built with a privacy-first approach, freya.Intelligence complies with SOC 2, ISO 27001, and GDPR standards, ensuring end-to-end protection of your regulatory data and user information.

Learn more about our Security framework.

Why freya is the best AI-Wiz for 
Regulatory Intelligence

01
Unified RIM Software Platform
One cloud-based system for registrations, submissions, labeling, content, and intelligence.
02
AI-First Automation
+
03
Global Regulatory Intelligence
+
04
Modular & Scalable
+
05
Purpose-Built for Life Sciences
+

Ready to Simplify Your Regulatory Journey?

How freya.intelligence Compares to Others

What Matters

  • Always Accessible
  • Predictive Intelligence
  • Effortless Collaboration
  • Seamless Connectivity
  • Global Readiness

  • Intuitive, one-click access to AI-powered insights through a unified platform
  • AI/ML-enabled to uncover trends and insights for forward-looking decisions
  • Real-time content sharing, workflow management, and audit tracking across Global teams
  • Built with modular design, application composability, and data model flexibility
  • Covers 200+ markets and tracks 100k+ regulations, across all major health authorities

With Other Platforms

  • Complex interfaces requiring setup
  • Primarily analytics based on historical data
  • Limited collaboration and workflow transparency
  • Often rigid and siloed with limited integration capabilities
  • Limited regions and fragmented regulatory data