OPERATIONAL SERVICES

Submission Management
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Successful Management/Delivery of Global Lifecycle Submissions
- Project management for global submission
- Manage R&D submission team and submission for all major and minor submissions
- Successful management/delivery of global lifecycle submissions
- Global submission guidance interpretation and document authoring support
- Paper, eCTD and NeeS submission compilation, publishing and delivery
- Provide guidance/manage outsourcing of Structured Product Labeling (SPL)
- Content of labeling, drug listings, establishment registrations

Document Management
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- Strategic document management for acquisitions, mergers, divestments and litigations
- Document storage structures and support (archiving and dictionary management)
- Naming standards and placement rules
- Provide assessment of technology solutions for optimal document management
- Legacy document management (E.G. gap analysis, migration,formatting)

Publishing
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Successful Leadership/Publishing of Global Submissions
- Document QC and readiness
- Paper, Electronic, eCTD and NeeS
- Cross-referencing and hyperlinking strategies
- CTD granularity guidance
- ICH and global data standards

Information Management Systems
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- Content Management Systems
- Veeva (Vault)
- Documentum (EMC2)
- FirstDoc (CSC)
- SharePoint (Microsoft)
- GLS (Glemser)
- Publishing Systems
- Insight Publisher (Liquent)
- eCTDXpress (CSC)
- Extedo
- GlobalSubmit Publish
- DocuBridge (Lorenz)
- Registration Tracking Systems
- Insight Manager (Liquent)
- TRS Tracker (CSC)
- Trackwise (Sparta Systems)
- ArisGlobal
- DrugTrack (Lorenz)
- Vendor-neutral production selection
- System implementation, maintenance and upgrades
- User Requirement Specifications (URS), standards, process and training

Document/Data Migration
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- Data classification
- Conceptual data models
- Registration data
- Standards and templates
- Process and training