Regulatory Database

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 andKeyboard-72
     •  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.

Related pages:
     •  Regulatory Compliance
     •  Manufacturing Operations
     •  Research & Development
     •  Project Management
     •  Operations Improvement
     •  New Product Introduction