GCLP certification

A “clinical trial specimen analysis institution” is an organization designated by the Commissioner of the Ministry of Food and Drug Safety pursuant to Article 34-2, Paragraph 1, Item 2 of the Pharmaceutical Affairs Act to perform analyses on clinical trial specimens.

Our company was designated as a clinical trial sample analysis institution in 2024 in accordance with the Ministry of Food and Drug Safety’s GCLP (Good Clinical Laboratory Practice) standards,

and we operate a rigorous quality management system to ensure ultra-precise analysis of clinical trial samples.

Translated with DeepL.com (free version)

Designation as a Cleanroom Clinical Trial Sample Analysis Facility (GCLP)

We are a Good Clinical Laboratory Practice (GCLP) facility designated by the Ministry of Food and Drug Safety, and we possess world-class capabilities in ultra-high-sensitivity biomarker analysis and
production infrastructure.

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The world's only cleanroom-based clinical trial sample analysis

In the world’s only cleanroom environment that completely blocks external contamination,
our skilled professionals provide clinical trial sample analysis with world-class accuracy using our own optimized, in-house protocols.

With our proven expertise, we have performed more than 60,000 analyses for the National Institute of Health, domestic and global medical institutions, pharmaceutical companies, and biotech firms.

We validate analytical methods and perform sample analysis in accordance with optimized standard operating procedures (SOPs) that comply with international standards (ICH).

Insightful

We have the most extensive experience in Asia in analyzing blood biomarkers and can provide systematic collaboration starting from the research design phase.