CDMO services
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Contract Development and Manufacturing (CDMO)
Global Level GMP Operating System
Our services include establishing GMP quality control capabilities through regulatory inspections by domestic and international agencies, as well as securing competence for exporting products.
| Category | Institution | Inspection Details | Result | Year |
|---|---|---|---|---|
| Domestic | MFDS | GMP Inspection | Compliant | 2018 |
| Client | GMP Inspection | Compliant | 2018 | |
| MFDS | Human Cell Management, Cell Processing Facility | Compliant | 2021 & 2023 | |
| Advanced Biopharmaceutical Manufacturing | Compliant | 2022 | ||
| MFDS | GMP Inspection | Compliant | 2022 | |
| GMP Inspection | Compliant | 2023 | ||
| International | Client | GMP Inspection | Compliant | 2020 |
| GMP Inspection | Compliant | 2020 | ||
| FDA(US) | GMP Inspection | Compliant | 2022 |
Key licenses for advanced biopharmaceutical CDMO business
Acquisition of GMP facility, quality system certification/license required for production of clinical-grade advanced biopharmaceutical.
Advanced Biopharmaceutical Raw Material Supply
Human Cell Management(License No. 4)
Supply of investigational medicinal products for clinical research
Cell Processing Facility(License No. 10)
Advanced Biopharmaceutical Manufacturer
Advanced Biopharmaceutical Manufacturer(License No. 37)
GMP Quality
Management System
Global Level GMP Operating System.
Establish and operate a GMP Quality Management System (QMS) in compliance with global regulations
GMP Quality System
Operation of
a quality management system
in compliance with national
and international regulatory
requirements
- Production System
- Facility System
- Quality Control & Monitoring
- Equipment System
- Quality Assurance System
- Material System
- Hygiene Control System
- Packaging & Labeling System