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
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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