i-Solutions’ Regulatory Database captures the critical items needed to manage Product Transfers through the transitional regulatory stages. It incorporates:
• the schedule structure based on dose form, strength, pack type and markets
• regulatory milestones from ‘Regulatory Submission Requirements Defined’
through ‘Receipt of Regulatory Approval’
• milestone durations and
• assigned resources.
The application provides progress reports including ‘Planned and Actual Percentage Complete’, overall ‘Project S-Curve’ and ‘Missed Milestone Analysis’ against the baseline schedule. The Regulatory Database provides pertinent information needed by Management to foresee and rectify schedule challenges.
• Regulatory Compliance
• Manufacturing Operations
• Research & Development
• Project Management
• Operations Improvement
• New Product Introduction