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Services
End-to-End CDMO Services based on technological Expertise

Regulatory Support
KOLON Biotech has built global top-level CMC expertise and a strong foundation.
We can provide the regulatory supports at every development stage from IND to BLA.
01
Preparation & Review
  • Common Technical Document (CTD)
  • Risk Management Plan (RMP)
  • Official meetings (e.g., Type A/B/C meetings)
02
Application
  • IND application
  • EOP meeting
  • BLA application
03
Maintenance Services
  • IND amendments and maintenance
  • Document update (CTD, RMP, protocol, etc.)
  • Regulatory support in accordance with client's development plan
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