Support Services for Analysis, Evaluation and Regulatory Approval
Welcome to the Daegu-Gyeongbuk Medical Cluster, the future of the global medical industry!
Support for new drug candidate analysis and technology evaluationGo
- Molecular design, pharmaceutical analyses, pharmacokinetics, cytotoxicity/safety, pharmacological efficacy evaluations, biophysical structure analyses
Contact : New Drug Development Center, Research Planning Team (053-790-5224)
Support for pharmaceutical product permits and licensingGo
- GMP facilities, production, analysis, and consultation for pharmaceuticals, license documentation
- Scope of support : pharmaceuticals production processing, analysis technology, EH&S, GMP facilities establishment and operation, application for clinical testing permits, application for new drug licenses
Contact : Clinical Drug Manufacturing Center, Research Planning Team (053-790-5836)
Laboratory animal research technology services (new drugs/medical devices)Go
- Support for new drug development : evaluation of drug efficacy using animal test subjects for the treatment of human diseases (tumors, metabolic diseases, neurologic and cardiovascular diseases), In vivo PK evaluation, preliminary toxicity studies
- Support for medical device development: medical device performance testing (biocompatibility of medical device materials, image-guided materials testing, etc.), biocompatibility safety assessment of medical devices (cytotoxicity, genotoxicity, blood compatibility, irritation testing, etc.)
Contact : Laboratory Animal Center, Research Planning Team (053-790-5799)
Support for pharmaceutical product analysisGo
- Support for analysis, analysis methods, and validation of raw materials and finished products
- Scope of support: : stability tests, lot release tests
Contact : Clinical Drug Manufacturing Center, Research Planning Team (053-790-5836)
Support for Medical Device Testing and Evaluation Go
- Support for electrical and mechanical safety tests, electromagnetic compatibility (EMC) tests, biological safety tests, performance and reliability evaluations, and biocompatibility testing required for regulatory approval
- Issuance of certified test reports accredited by the MFDS for surgical instruments, diagnostic devices, stimulators, in vitro diagnostic devices, syringes, syringe needles, and U-healthcare medical devices
- International certification support includes electromagnetic compatibility testing according to 51 standards, including IEC 60601-1-2 and other international standards
Contact : Electromagnetic Compatibility Assessment team , KIM TAE-HYUNG (053-790-5673)
EMC Chamber
10/3M Chamber
