,Regulatory Intelligence in Pharmacovigilance - Overview
Every stage of a product’s lifecycle — from development to post-market surveillance — is governed by rapidly changing regulatory frameworks. Keeping pace with these evolving global standards, especially within the pharmacovigilance domain, can be challenging due to diverse processes, regional variations, and language barriers.
Freyr’s Regulatory Intelligence in Pharmacovigilance bridges this gap by providing organizations with real-time monitoring, analysis, and interpretation of evolving PV regulations. Our specialized regulatory intelligence services in pharmacovigilance help ensure end-to-end compliance by identifying new and revised requirements across 150+ markets.
Freyr also integrates Safety Regulatory Intelligence into its framework, allowing teams to proactively respond to regulatory updates related to safety reporting, signal management, and Local QPPV requirements — ensuring both global and local alignment in compliance operations.
Comprehensive Approach to Regulatory Intelligence in Pharmacovigilance
Freyr’s approach combines automation, analytics, and expert interpretation to create a centralized hub for PV Intelligence and continuous global monitoring.
- Freya, Freyr’s AI-powered regulatory advisor, delivers global insights and safety updates from over 200 regulatory agencies.
- A holistic regulatory surveillance ecosystem ensures complete oversight of Safety Regulatory Intelligence, helping organizations detect and assess evolving safety obligations, new reporting mandates, and authority-driven updates.
- Freyr’s Regulatory Intelligence services capture and archive crucial information, including Foreign Measures Taken Reports, inspection findings, and authority communications, helping clients maintain readiness and compliance documentation.
- Tailored country-level insights support compliance with region-specific requirements, including Local QPPV appointment and monitoring obligations.
Regulatory Intelligence in Pharmacovigilance
Freyr’s intelligent, cloud-based platform simplifies how organizations interpret, manage, and apply PV regulations globally.
- Comprehensive Regulatory Coverage: Global monitoring of 500+ health authorities, 100+ product categories, and 50+ trade associations.
- Integrated PV Intelligence: Supports cross-country comparisons for topics like ICSR Management, Periodic Reports, and Risk Management Plans.
- Safety-Focused Surveillance: Leverages Safety Regulatory Intelligence to identify new safety reporting procedures, adverse event reporting changes, and pharmacovigilance inspection requirements.
- Localized Expertise: Enables the management of Local QPPV requirements and supports real-time updates from regional regulatory bodies.
- Continuous Improvement: Delivers periodic newsletters and reports, including updates on Foreign Measures Taken Reports, to help organizations maintain vigilance and strategic awareness.
- Real-time access to Regulatory Intelligence in Pharmacovigilance for 150+ global markets.
- Comprehensive Regulatory Intelligence services that streamline compliance and enhance regulatory readiness.
- Integrated Safety Regulatory Intelligence ensuring proactive safety compliance and risk mitigation.
- Strengthened PV strategies through continuous PV Intelligence monitoring and authority trend analysis.
- Simplified Local legislation monitoring for region-specific compliance.
- Data-driven insights from Foreign Measures Taken Reports supporting faster, compliant decision-making.
- Customised reports and newsletters for real time training and change management
