Quality Management System(QMS)
The Foundation of Excellence
To deliver reliable non-clinical data that meets global regulatory requirements,
we operate a state-of-the-art Quality Assurance (QA) system.
Data Integrity Management
We rigorously manage data reliability and traceability to comply with GLP (Good Laboratory Practice) requirements from global regulatory bodies, including the FDA. Data integrity is essential in the drug development process, and we have implemented advanced systems and processes to ensure this.
ProVantis System Implementation
Leveraging the ProVantis system, widely used by global CROs, we have digitized data management and reporting processes. This system enhances the accuracy and security of real-time data recording and tracking, providing optimal data for IND and NDA submissions.
Electronic Logbook System
As the sole organization in Korea managing all test records through an electronic logbook system, we maximize data security, transparency, and efficiency by replacing paper records with digital data. This enhances data accessibility for real-time review and management.
