Overview
Our
quality management system complies with NMPA, FDA, and EMA regulations, as well
as ICH Q8-Q10 guidelines on lifecycle management, ensuring high product quality
from R&D through to commercial manufacturing. This system has been
inspected and certified by multiple regulatory authorities.
BioDlink (TOT BIOPHARM) also
has a robust inspection response system, with extensive experience in handling
regulatory inspections for drug registration.