Pharmacovigilance

BlueBallon has an experienced Pharmacovigilance Service Team. We have extensive experience in pharmacovigilance both at home and abroad. We are proficient in domestic and foreign pharmacovigilance laws and regulations and related submission process, and we are able to provide all-around and high-quality pharmacovigilance services throughout the entire lifecycle of products. Our service includes but is not limited to the establishment of a pharmacovigilance system that is compliant with GVP requirements, pharmacovigilance system document writing, pharmacovigilance system docking/maintenance/management, clinical and post-marketing safety report management, medical writing, risk identification and management, etc.

The PV Team has undertaken approximately 60 clinical trial PV service projects, including China-Japa, China-US-Australia and China-US dual-reporting projects, covering therapeutic areas such as neurology, respiratory (including COVID-19), hepatobiliary, skin, oncology, infection, immunity, vascular, eye organs, analgesia, etc., involving chemical drugs, biological drugs, vaccines, etc.





PV Consulting
PV System Development
PV System Documentation Writing & Updating & Compliance Audit
Product Leaflet Updating
Clinical/Post-market CSR Processing and Submission
Medical Writing (DSUR, PSUR, RCP, RMP)
Literature Search
PV System Deployment
Service Fields
Oncology Oncology
Oncology
Cardiovascular Cardiovascular
Cardiovascular
Infections Infections
Infections
Neurology Neurology
Neurology
Respiratory Respiratory
Respiratory