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KOLON BIOTECH
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Services
End-to-End CDMO Services based on
technological Expertise
Regulatory Support
Overview
GMP Manufacturing
Quality Management
Regulatory Support
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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