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Regulatory Information Management RIMS

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:

  1. 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.
  2. Impact assessment: Assessing potential impact plan the steps for managing risks.
  3. 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.
  4. 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.
  5. 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.

Manage effectively all registration and license information. Whether launching new product or life cycle activities, our solution provides users with the key information and functionality to support all activities with project management, event management, wizards and more

   

  • Designed to quickly deploy foundational RIM capabilities through agile methods

  • Pre-configured for rapid implementation with a “production-ready” validations

  • Based on industry-leading practices and implementations in RIM

  • Improved user adoption via out-of-the-box capabilities and proven training methods

  • Faster realization of business objectives and benefits

Product/License Tracking

Regulatory license management helps managing licenses, permits, and authorizations required to comply with regulatory requirements. It includes obtaining and maintaining licenses, renewing licenses and permits as necessary, and ensuring compliance with regulatory requirements.

Regulatory license management using our solution typically involves several steps, including:

  1. License Identification: Identifying the licenses and permits required to comply with regulatory requirements.
  2. Application Process: Obtaining and completing the necessary application forms, providing required information and documentation, and submitting the application to the regulatory agency.
  3. License Tracking: the status of license applications, renewals, and expiration dates to ensure that licenses and permits are Tracking up-to-date.
  4. Compliance Monitoring: Monitoring compliance with regulatory requirements, including reporting requirements, and maintaining documentation to demonstrate compliance.
  5. License Renewal: Renewing licenses and permits as necessary, including updating information and documentation as required. required, such as when a business activity is discontinued or transferred to another company.
  6. Monitoring: Proactively alerting teams on upcoming obligations, commitments and Renewals

Effective regulatory license management is critical for companies to comply with regulatory requirements and operate within the bounds of the Regulation/law. By using our solutions effectively, companies can minimize the risk of legal and financial consequences, and ensure business continuity.

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