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As compounds move through the development process, our support services provide the expertise critical to meeting stringent regulatory requirements.
  • Novel Product Engineering Merged w/Regulatory Strategy
  • Expert Advice from Submission through Pre-Approval Inspection
  • Due Diligence for Products, Compounds, Process and Supply Chain
  • Drug Development Program Management
  • CRO / CMO Selection
  • Quality Risk Analysis for Products and Processes
  • Methods Development
  • Expert Testimony and Reports
  • Life Cycle Management
  • Owner-based Process Knowledge Systems