Submission Tracker, Issue Log Key to Agile Regulatory Publishing
Nov05

Submission Tracker, Issue Log Key to Agile Regulatory Publishing

The Submission Tracker is a list of every document that will be submitted to an Agency. The Submission Owner is responsible for the Submission Tracker, including its content, availability, table of contents sections, document production date, title, ordering and status of the document in the publishing process. For simple submissions (e.g. small amendments) the Submission Tracker could simply be a list of documents. Either way the Submission Tracker should have attributes that help estimate the publishing effort

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The Case for Tracking Regulatory Submissions
Dec15

The Case for Tracking Regulatory Submissions

The Submission Tracker assigns key dates to deliverables, for example, when a deliverable will be provided for publishing and when certain tasks related to that deliverable must be completed to in order to promote it to submission ready. The tracker is used to determine if submission content is being provided according to schedule and if publishers are completing tasks on time.

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How Mergers & Acquisitions Impact Regulatory Operations Part 1

During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.

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