FDA Submission Tracking and Planning is a pharmaceutical application designed to assist the Regulatory Affairs department in planning and tracking all significant events related to filing submissions with the FDA. The major benefits of the Submission Tracking and Planning application are:

• Consolidating all events associated with FDA submissions in one searchable database. This data can be sorted and searched for pertinent information.
• Facilitating reporting by selection type. This feature facilitates the filing of submission information according to type.
• Linking pertinent reports to history entries.

FDA Submission Tracking

The Submission Tracking module is designed to assist the Regulatory Affairs department in tracking and logging all communication with the FDA.  Use the Submission Tracking module to log submissions, correspondence, phone calls, faxes, letters, meetings, and any other interactions.

Each product contains the history of all FDA submissions for the product with the FDA assigned NDA and IND numbers.

Reports are created based on user selected filters. Each report can contain all historical information or information selected by the filter. The filters are provided to accommodate filing of reports according the selected category of information.

FDA Submissions Planning

The Submissions Planning component is designed to assist the Regulatory Affairs department in monitoring and planning for required FDA submissions. The database insures that all of the current FDA requirements for quarterly and annual submissions are met. It provides a way for the department to anticipate workload, schedule activities and research required information prior to the submission.

The Submissions Planning module includes:

Automatically Generated Advance Notices - This routine automatically generates advance notices and submission due date entries based on a product's NDA date and IND date. The routine can be run for all products for any year or for one selected product for any year. The notices are typically used by the Submissions group, to notify other departments involved in preparing for an upcoming submission. The ability to generate advance notices for one specific product is particularly useful for new product submissions.

Entry of Significant Activities - The submissions group can enter all activities that must occur prior to the required submission. These entries are used to insure that all regulations are satisfied and are part of the reporting system.

Reports - A standard set of reports can be generated from a report selection form. Using this form, you can generate reports using date range criteria, product selection criteria, and choosing whether to include advance notices in the report. Report selection is based on user criteria. New reports can be created based on our client's requirements.

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