Our Services
Comprehensive pharmacovigilance solutions ensuring patient safety and regulatory compliance worldwide.
Aggregate Reports
Support for PSUR, PBRER, and DSUR to maintain regulatory standards and safety monitoring.
Case Processing
Efficient individual case safety report processing and expert medical review for accurate outcomes.
Common Questions
What services do you offer?
We provide end-to-end pharmacovigilance including ICSR processing, literature screening, narrative writing, aggregate reports, and risk management support.
How do you ensure safety?
Our team applies rigorous medical review and signal detection methodologies to safeguard patient health and maintain regulatory compliance globally.
Who can use your services?
Pharmaceutical and biotech companies worldwide seeking expert pharmacovigilance support to manage safety data and regulatory obligations trust us.
What is ICSR processing?
ICSR processing involves handling and medically reviewing individual case safety reports to monitor adverse drug reactions.
How do you handle global reports?
We conduct comprehensive global literature screening and aggregate safety report support, ensuring adherence to international regulatory standards.
What is risk management?
Risk management includes detecting safety signals and assessing risks to aid companies in minimizing potential patient safety issues.
Our Projects
Delivering comprehensive pharmacovigilance solutions to ensure patient safety worldwide.
ICSR Processing
Accurate individual case safety report handling and review.
Literature Screening
Global evaluation of scientific literature for safety signals.
Aggregate Reports
Support for PSUR, PBRER, and DSUR safety report preparation.
Risk Management
Assistance with risk assessment and signal detection strategies.