Pharmacovigilance
Active Pharmacovigilance service in accordance
with reinforced changing global regulations
expand drug monitoring hub Pharmacovigilance systems worldwide.
We have extensive experience in drug monitoring collaboration with domestic
and foreign partners, response from domestic and foreign regulators, and safety
information management in clinical trials and post-marketing research.
Through experience in all cycles of non-clinical research, clinical research and
post-marketing drug monitoring, pharmaceutical companies that start
developing new drugs and medical devices, clinical trials according to domestic
and external safety regulations, and drug monitoring will be carried out.
- Real World Evidence Study for Pharmacovigilance
- Regulatory PMS
- KIDS Reporting
- Medical Monitoring by Medical Doctor
- Pharmacovigilance supporting in accordance with regional regulatory requirements
- Safety management
- SAE processing
- SOP development and management
- PSUR(Periodic Safety Update Report) development
- DSUR(Development Safety Update Report) development
- Pharmacovigilance audit
- RMP(Risk Management Plan) development
