Examining the Business Case for Small Pharma Transitioning to an In-House RIM

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•   Company level of development, pipeline, and five-year plan
  • Company existing methods of regulatory information management – manual, vendor-dependent
  • Lack of in-house expertise for decision-making, depending on vendor to make strategic decisions
•   Rationale for moving to in-house RIM
  • Expertise
  • Company pipeline
  • Definition of RIM for this company
•   The Plan
  • Parallel RFP for RIM and RDMS
  • Budget, Resources, Validation
• Present and Future Plan