Pharmaceutical & Medical Device
Drug, Device & Diagnostics
The core expert group for pharmaceutical and medical device regulatory practice. Includes former MFDS regulators, principal investigators from major university hospitals, and Regulatory Affairs (RA) veterans from global pharmaceutical companies.
Specializations
- Small molecule, natural product, biologics licensing
- Class I–IV medical device approval
- GMP / KGMP system implementation
- Clinical trial protocol design (IND, IDE)
- Post-market surveillance (PMS)
- Global regulatory strategy (FDA, EMA, NMPA)