LORENZ Life Sciences Group

LORENZ combines regulatory information management with product-data management, controlled content workflows and electronic submission publishing. Its software supports IDMP/SPOR and xEVMPD data preparation, submission lifecycle tracking and regulatory content reuse, and LORENZ's own experts install, migrate and configure it.

What It Helps Teams Do

• Manage regulatory product information, submissions, authority correspondence, activities and approvals in a centralized RIM platform.
• Prepare structured medicinal-product data for IDMP and SPOR compliance, and create or update xEVMPD messages for EMA submissions.
• Plan and monitor submission groupings, renewals, milestones, responsibilities and due dates with alerts, dashboards and reports.
• Compile, publish, import and review eCTD submissions, with support for other formats including VNeeS, HTML, PDF and paper.
• Reuse regulatory content files, hyperlinks and node properties across lifecycle sequences while tracking revisions and changes.
• Manage regulatory content through review and approval workflows, check-in/check-out, version control, auditing and metadata management.

Best Fit

• Regulatory teams needing software to maintain product information, coordinate submission activities and manage registration messages across the product lifecycle.
• Organizations adopting docuBridge or eValidator that want installation, validation, migration, configuration and support from LORENZ's own experts.
• Teams that want software for regulatory information and submissions rather than outsourcing regulatory writing or operations.