Gene therapy products: regulatory expectations and challenges for the industry
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SMARTTRACE
A landscape for managing global submissions
SMARTTRACE is a Regulatory Information and Process Management system for managing the workflow of regulatory submissions from the planning phase through to submission and archive. This tool allows PharmaLex to plan, execute and track Regulatory submissions for our clients worldwide in a most effective and compliant manner.
Features
- Follows the workflow of a regulatory submission from the very start of planning, through to it being submitted and archived
- Allows Regulatory Submission Managers to request publishing support when it’s required
- Allows the user to easily navigate to and manage the source documents used within the regulatory submission
- Allows the user to easily navigate to an archived copy of the submission and all associated correspondence documentation
- Support exchange of documentation within the project team as well as with clients
- Automated notifications to streamline communication with stakeholders
Benefits
- Submission Managers can easily monitor and report on the status of their regulatory submissions
- A single system connecting the publishing and submission management process
- A single system connecting document management with the submission management process
- A single system connecting the archive with the submission management process
- Automatic notifications streamline the communication path and ensure stakeholders are informed of all changes to the management of a regulatory submission
- Proper planning information allow a more efficient and effective resource allocation and utilization
