A landscape for managing global submissions
SMARTDECISIONS is a Regulatory Intelligence system for managing officially published Health Authority guidelines, combined with PharmaLex experience and recommended best practices. This tool allows PharmaLex Regulatory experts across the globe to share and access important Regulatory Intelligence information as well as practical submission experience, and finally to improve our Regulatory solutions to our clients.
- 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
- 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
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