About this user
KEMTI is GLP certified by the Korea Food & Drug Administration (KFDA) for medicines, functional food, and cosmetics, Ministry of Agriculture and Forestry (MAF) for pesticides, and Ministry of Environment (MOE) for industrial chemicals.
We are located in Incheon, South Korea, 20 km from the world's third largest cargo airport and can handle customs issues for shipping samples and test articles into Korea.
We are a GLP facility conforming to OECD principles and provide medical device biocompatibility test services following GLP and ISO 10993 standards. We are a GMP certifying body for the Korean FDA for medical device manufacturers and have more than 10 years of experience with products for cardiovascular, wounds, orthopedic, surgical instruments, contraceptives, acupuncture needles and contact lenses.
For our foreign customers interested in exporting medical devices into Korea, we provide both testing and audit services required by Korean regulators.
Consulting and preparation for meeting Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Material Safety Data Sheets (MSDS), and Registration, Evaluation and Authorization of Chemicals (REACH) is available.
Our services are available in both Korean and English.
We have 2,434 m2 of state-of-the-art GLP facility floor space, instruments and equipment to produce quality studies.
We offer KOLAS (Korean NIST equivalent) certified chemical analysis services.
Please contact us for any questions you may have!
Occupation
Toxicology, Nanotechnology, Biochemistry, Molecular Biology, Bioengineering, DVM
Interests
Nanotechnology, GLP, pharmaceuticals, chemicals, GMP, GXP, toxicology
