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Regulatory Information Management (Global Submission Management and Registration Tracking)
Global organizations are struggling with the challenges of planning, managing and submitting global dossiers from document creation through post-approval stages. This discipline requires consistent tracking of local health authority requirements, efficient planning for emerging content, management of lifecycle metadata and effective allocation of global resources. But most organizations don’t have the required visibility into global project planning or the impact of changes to submission plans. Traditionally, global companies don’t have an organization-wide understanding of regional/local requirements as this knowledge usually resides within affiliate companies and is not accessible by the rest of the organization. This often means that the company does not have an understanding of the nuances of local requirements vs. preferences and communication of these requirements becomes anecdotal at best. Geography and silos add complexity to the challenges of managing global regulatory information.
Octagon partnered with some of industry’s most innovative Regulatory professionals to develop the Submission Manager Business Application. It is designed to address the significant challenges of coordinating, planning and managing the many submission components required to support global registrations. Octagon’s process-centric approach leverages submission standards and exploits common requirements globally. Submission Manager employs a sophisticated rules engine to codify requirements at an enterprise level and provide one source for all Health Authority requirements, submission content and metadata.
The Submission Manager’s simple user interface automates planning and offers reusable content plan templates based on current health authority requirements. Capturing this information and applying it through the Submission Manager Business Application ensures that requirements are interpreted consistently worldwide. It also provides much-needed flexibility to the Dossier Planning staff so they can react to changing submission strategies more rapidly.
This Business Application also offers optional support for electronic and paper submissions.
