Phase 2 Support

Phase 2 Support
Product Description

Setting the stage for the commercial process:• Route or step rebuild
• Process optimization &demonstration
• Impurities assessment & synthesis
• Full structure characterization &elucidation
• Analytical method development &qualification
• Stress studies & ICH stability standards
• CMC gap analysis for commercialization

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPhI since
  • 3
    Certificates
Contract Service
Manufacturer/Innovator

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPhI since
  • 3
    Certificates
Contract Service
Manufacturer/Innovator

More Products from Eurofins CDMO Alphora Inc

  • Early Phase Support

    Product Early Phase Support

    From the lab to the plant:• Development of new, scalable API route options
    • Process safety and hazards assessment
    • cGMP starting material assessment& establishment of regulatory concept
    • Starting material & other raw materials sourcing and development
    • Polymorph screening & salt selection
    • Analytical method screening &preliminary stability profile
    • Pre-formulation & pre-clinical supply
  • Phase 3 or Commercial Support

    Product Phase 3 or Commercial Support

    Taking the molecule to market• Fate & purge studies
    • Impurities marker synthesis &qualification
    • Design of experiments
    • Critical process parameters studies
    • Preparation for, and execution ofprocess validation
    • Continuing CMC support during &after market launch
    • Technology transfer to client’s APICMO, as applicable

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