freya.intelligence: 
Empower Your Regulatory Decisions.

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.

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.

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.

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 and QMS documentation.

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.

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 95,000+ regulations across 200+ markets, Freya delivers precise, reference-backed insights in seconds eliminating manual searches and enabling faster, more confident compliance decisions.

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.

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.

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.

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.