Registration Management: Empower Global Compliance with AI-First Clarity.
For regulatory professionals overseeing product registration and lifecycle events across multiple regions, the complexity of tracking and maintaining global approvals is escalating.
From evolving IDMP and xEVMPD standards to diverse country-specific requirements, managing product data with precision is more critical than ever. Misaligned records, fragmented systems, or delayed updates can jeopardize compliance, disrupt supply chains, and delay market access.
Key Challenges in Global Registration Management.
Lack of Visibility Across Product Registrations
Managing registrations across dozens of markets-each with its own timelines, formats, and regulatory rules-makes it difficult to maintain an accurate, real-time view of product status. Without a centralized system, teams risk duplicate efforts, missed renewals, and non-compliance.
Manual Lifecycle Tracking of Approvals & Renewals
Tracking marketing authorizations, renewals, withdrawals, and variations manually introduces risk. Spreadsheet-based systems or siloed RIMS tools lack the automation needed to track changes in real-time across products, sites, and SKUs.
Fragmented Product Master Data
Registration information is often dispersed across multiple systems-making it difficult to maintain a consistent product master across global markets. Errors in registration data, health authority correspondence, or submission history can derail change implementations.
Keeping Up with Global Regulatory Evolution
Regulations like IDMP, SPOR, and xEVMPD are shifting toward structured data submissions. Organizations must ensure that registration data is harmonized and ready for future compliance formats-something legacy systems can’t support.
How freya fusion Transforms Registration Management?
freya.register, a core module of Freya Fusion, brings structure and intelligence to your global registration workflows:
Centralized Global Registration Repository
Maintain a single source of truth for product, site, and market registrations-mapped by MA holder, application type, approval date, and lifecycle status.
Automated Lifecycle Event Tracking
Track variations, renewals, withdrawals, and sunset dates with configurable alerts. Never miss a milestone again.
Structured Data Compliance for IDMP/xEVMPD
Capture and validate product master data in structured formats, ready for SPOR, PMS, and health authority submissions.
Change Impact Intelligence
Assess registration impact automatically before initiating changes-link applications, product families, and regulatory events with AI-enabled mapping.
Integrated Workflow with Submissions, Product & Lifecycle Modules
Seamlessly connect product data and lifecycle updates to registrations-ensuring every change reflects across systems with traceability.
Built-in Product Master Linkage
Access accurate, region-specific product data-such as strengths, formulations, and packaging-directly within registration records to reduce duplication and boost accuracy
Build Regulatory Agility with
Smart Registration Systems.
Forward-looking organizations are adopting unified, AI-first registration management solutions too:
Avoid registration data silos with a harmonized global repository.
Reduce the effort spent on tracking lifecycle events.
Accelerate change implementation timelines.
Prepare for structured data mandates like IDMP and xEVMPD.
Align stakeholders across regulatory, quality, and compliance.
Make Registration Compliance Seamless.
Whether you're managing 50 registrations or 5,000 across multiple markets,
freya.register ensures you stay compliant, responsive, and future-ready.