RegDocs Connect Reviews & Product Details

Key Features and Functionality: RegDocs Connect is cloud-based regulatory document management system (EDMS) software designed for pharmaceutical and biotech organizations to manage regulatory submissions, health authority communications, and product registration activities. The system provides structured document management and real-time visibility into submission readiness across multiple countries and regulatory agencies. Core capabilities: - Regulatory Navigator: Interactive dashboard displaying submission progress by product, country, application, and sequence with completion percentages and document status tracking - Submission Plan Management: Create and manage submission plans with required documents, document owners, and due dates for application preparation - Regulatory Activities Management: Manage sequences for multi-country submissions with ability to add, copy, and move documents between applications and sequences - Document Lifecycle Management: Configurable QC, review, approval, and electronic signature workflows tailored to document types - Correspondence & Commitment Management: Record and track all health authority communications with associated commitments and follow-up actions in a centralized commitment log - File Plan Configuration: Define workflow requirements (QC, review, approval) by document type to ensure appropriate oversight - Final Submission Archive: Store completed submissions in the system for regulatory reference and inspection readiness - Export to Zip: Package submission documents for electronic submission to health authorities Compliance: 21 CFR Part 11 and EudraLex Annex 11 compliant electronic signatures and audit trails, hosted on Microsoft Azure with SOC 2 Type I certification. Problems solved: Pharmaceutical and biotech organizations managing regulatory submissions across multiple countries face submission timeline delays from manual document tracking in Excel, difficulty reusing documents across related applications and sequences, lack of real-time visibility into submission completeness, manual coordination of health authority correspondence and commitments, and inefficient document packaging for submission deliverables. Value delivered: - Submission readiness visibility: Regulatory Navigator provides instant visual overview of submission completion status by country and application - Accelerated submission timelines: Structured workflows and document reuse capabilities reduce repetitive work across applications - Centralized regulatory intelligence: All health authority correspondence and commitments tracked in one system with clear follow-up visibility - Simplified document management: Intuitive actions for moving and copying documents between applications reduce manual file management - Rapid implementation: 4-8 week implementation with included validation package - Inspection readiness: Centralized archive of all submission documents and regulatory activities Target users: Regulatory Affairs professionals, Regulatory Operations Managers, Submission Managers, and Regulatory Documentation Specialists at pharmaceutical and biotech companies managing product registrations and regulatory submissions across multiple markets.