Pharmacovigilance

Consisting of the Medical Director and the pharmacists, our Pharmacovigilance Team supports our clients in tasks related to the safety information of drugs, medical devices, etc. before and after marketing.
We keep up to date with dynamic changes in local and international regulations to properly conduct the safety monitoring and safety reporting. All of our pharmacovigilance services are conducted in accordance with ICH guidelines and applicable international regulations and we serve as a drug safety representative who conducts tasks related to drug safety both in the pre-marketing clinical study and in the post-marketing pharmacovigilance setting.
Safety Management Set-up and Management of a Pharmacovigilance System
PSUR/PBRER Development RMP Development
Local Safety Support Regarding Local PV Legislation Literature Surveillance
PV SOP writing