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Emerging companies are faced with the challenges of planning and managing submission content that is coming from multiple sources including functional areas, medical writing departments, contract research organizations and consultants. Octagon's Quantum Submission Manager helps these companies to track planned content, compile the application in an appropriate format (paper, NeeS or eCTD) and then support lifecycle maintenance activities for the submission. The non-technical interface, best practice-based workflows and preconfigured submission structures accelerate the process and reduce resource requirements for submission management and production.
Global Life Sciences Companies
Global organizations are struggling with the challenges of planning, managing and submitting global dossiers from document creation through post-approval stages.
This Regulatory Information Management 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's Quantum Submission Manager enables:
- Enterprise access to global regulatory information through robust search and reporting functionality
- Detailed tracking of health authority requirements and a mechanism for operationalizing them globally
- Effective planning for multi-country, global projects that leverages a sophisticated rules engine to codify requirements at an enterprise level
- Efficient management of emerging content
- Rapid response to changes in strategy
Octagon partnered with some of industry’s most innovative Regulatory professionals to develop the Submission Manager as the “one source” for all Health Authority requirements, submission content and metadata.
| Quantum Modules | ||
| Quantum Document Publisher™ | Quantum Content Manager™ | Quantum Submission Manager ™ |
