Submission Management

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
Publishing

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
Document/Data Migration
  • Data classification
  • Conceptual data models
  • Registration data
  • Standards and templates
  • Process and training
Document Management
  • 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 (eg, gap analysis, migration, formatting)
Information Management Systems
  • 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