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CMC Support to Commercial Manufacturing

  • Analytical Method Development report with:
    • Preliminary degradation data
    • Physical and chemical characteristics
  • Standard test procedures for:
    • Raw material, intermediates and finished product
    • In-process controls
    • Cleaning methods
  • Characterization data for impurities and reference standards
  • Analytical method qualification/validation report for final product and Key Starting Materials (KSMs)
  • Report for “Cut-Off”/“Carry over studies” data with scientific rationale
  • Impurity profiling for KSMs and final product
  • Report on holding study (wet and packaged)
  • Report on indicative stability studies
  • Analytical testing and release
    • Primary reference standard qualification and characterization (purity, assay, ROI, KF, residual solvents, etc.)
    • COA issuance
    • Establishment of qualified reference standard – R&D/Separation
    • Packaging/Storage
    • Stability studies (ICH conditions)
    • Analytical method transfer
  • Physical state characterization and polymorph screening