Safety and Pharmacovigilance
Led by a multidisciplinary team of Medical Doctors and Pharmacologists, Abiozen delivers rigorous safety reporting and post-marketing surveillance to ensure patient safety and global regulatory alignment.
Governance
MD-Led Oversight
Validation
Clinical Pharmacology
PV Framework
Safety Reporting
Expedited global agency submissions.
Signal Detection
Advanced post-marketing surveillance.
Risk Management
REMS and mitigation planning.
Comprehensive Global Safety Monitoring
Our pharmacovigilance team offers extensive experience in safety reporting for both clinical trials and post-marketing surveillance worldwide. We bridge clinical expertise with strict regulatory adherence.
"We leverage sophisticated safety databases and strict reporting criteria to safeguard patient health and maintain regulatory standing."
Safety Databases
Expertise in leading PV software for streamlined case processing and data integrity.
Global Compliance
Deep understanding of regional PV regulations across FDA, EMA, and international markets.
Electronic Submission
Seamless gateway submissions utilizing MedWatch and CIOMS standardized forms.
Medical Review
Clinically-driven assessment of adverse events by qualified medical professionals.
Our PV Service Portfolio
Rigorous safety workflows designed for accuracy, speed, and patient safety.
Pharmacovigilance Services
- Case Intake & Triage
- Case Processing
- Medical Coding
- Case Narration
- Quality Checks
- Medical Review
PV Writing Services
Aggregate Reporting
Expert preparation of PADER, PBRERs, and comprehensive safety reports.
PSUR & DSUR Writing
Periodic and Development Safety Update Reports authored by medical experts.