DT&CRO

Safety evaluation center in Cheoin-gu, Yongin, Gyeonggi-do, running non-clinical toxicology studies across GLP test items; the efficacy evaluation and analysis centers are also in Yongin.

Clinical division in Seocho-gu, Seoul, providing development-stage consulting, phase 1 to 3 trials for approval, post-approval trials and pharmacovigilance; it says it was the first Korean CRO certified to ISO 14155 for medical device trials.

Converts non-clinical study data into the FDA submission format SEND, integrates laboratory information management systems (LIMS) and offers FDA IND and NDA consulting.

Bundles feasibility review, non-clinical PK/PD evaluation, clinical design and conduct, and regulatory strategy for improved and combination drugs; the company says it has run 54 phase 1 trials of improved drugs, including 30 combination-drug bioequivalence studies, and 26 combination-drug toxicity studies.

Signed a business agreement with Matica BioLabs, a cell and gene therapy CDMO and subsidiary of CHA Biotech, to offer full-cycle drug development services linking CDMO manufacturing with non-clinical and clinical studies.

Received new GLP certification from the Ministry of Food and Drug Safety for phototoxicity (3T3) and multi-ion channel (Cav and Nav) tests for drugs; for medical devices, its PKPD center gained GLP facility certification and muscle implantation testing was added.

Developing AI screening that flags liver whole slide images (WSI) with suspected abnormal findings in non-clinical toxicity studies, plus a platform linking pathology images with study data; pathologists make the final reading, and phase 1 is targeted for completion in April 2027.