Regulatory Support
Services for Regulatory CMC Strategy
  • Regulatory guidance and Interpretation of global regulations in accordance with ICH, China NMPA, US FDA, and EMA guidelines, and other global regulations

  • Preparation of Pre-IND package and Meeting packages, Interaction with HA and Response to IRs from HA

  • Setting of phase-appropriate testing acceptance criteria for specifications

  • Analytical comparability exercise from IND phase to Post-BLA

  • CMC Risk assessments for raw materials, manufacturing process, testing, formulation, container closure and format changes

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