Regulatory Support
Global CMC Submission
  • Preparation, Writing and Review of CMC documents in CTD format

  • Preparation of  CMC meeting documents and Response to IRs from HA

  • Submission of application documents in eCTD format

Equipped with vast experience, knowledge and capability
  • Our team has rich experience in application, review and approval of IND and BLA for NMPA and FDA.

  • Our team can provide CMC guidance and interpretation in accordance with ICH, China NMPA, US FDA, and EMA guidelines, and other global regulations.

  • Our ream can provide the progress tracking of CDE/FDA review process by actively communicating with HA and adequately responding to IRs from HA.

  • Our team has extensive experience in FDA on-site inspection.

  • Our team can provide FDA compliance for GMP manufacturing and testing.


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