Regulatory information management in our solution helps with planning, organizing, and managing regulatory projects to ensure that they are completed on time and meet regulatory requirements. It involves coordinating and communicating with various stakeholders (internal and external those who do not have access to the system), including regulatory agencies, project team members, and related parties, to ensure that regulatory projects are completed successfully.
Our RIM manages several steps, including:
- Planning: Developing a project plan that outlines the project (new product introduction or change management for manufacturing / shelf life / labeling) scope, objectives and timelines and activity.
- Impact assessment: Assessing potential impact plan the steps for managing risks.
- Stakeholder Engagement: Identifying and engaging with stakeholders, including regulatory agencies, project team members, and affected parties, to ensure that their needs and concerns are addressed.
- Monitoring and Evaluation: Monitoring registrations and change management requests progress against the plan, identifying any issues or deviations from the plan, and taking steps as necessary.
- Reporting: Providing regular progress reports to stakeholders, including regulatory agencies, project team members, and affected parties, to keep them informed of the project’s progress.