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CMC Services

CMC requirements depends on the stage of development, dosage form, physicochemical characteristics of drug, patient population, and indication. Strategizing at early stages of development by understanding unique challenges of each project is utmost important. Highly experienced CMC staff at Western BioPharma can help you by providing your project specific CMC strategy and executing together with you.

  • CMC Strategy, Developmental Stage Specific for DS & DP
  • Regulatory CMC
  • DS Custom Synthesis & Characterization Support
  • CDMO/CMO Due Diligence, Selection, and Management for DS & DP
  • Formulation (Non-clinical and Clinical), Process, and Packaging Development
  • Management of ICH Stability Studies and Data Assessment
  • Sterilization Guidance and Vendor Management
  • Author and Review of Manufacturing Batch Records