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

• 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)

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

• 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

• Data classification
• Conceptual data models
• Registration data
• Standards and templates
• Process and training