Drug Regulatory Electronic Affair Management
A Drug Regulatory Electronic Affair Management tool is a specialized software designed to streamline and automate the submission, tracking, and management of regulatory filings for pharmaceutical companies.
Key features include:
Product Registry: Structured database for managing the lifecycle of product information in accordance with EU Marketing Authorisation data
Compliance Tracking: Tracks submission statuses, deadlines, and regulatory approvals, ensuring adherence to local and international regulations.
Collaboration Tools: Enables cross-functional collaboration between regulatory, R&D, and quality teams, improving communication and transparency.
Automated Workflows: Automates key processes such as procedure management and submission to reduce manual errors and accelerate timelines.
Document Management: Centralized repository for all regulatory documents, ensuring version control, real-time updates, and secure access.
This tool helps pharmaceutical companies stay compliant, manage global regulatory requirements efficiently, and reduce time-to-market for new drugs
