Comprehensive Pharmacovigilance & Drug Safety Services
Our pharmacovigilance services ensure the highest standards of drug safety monitoring and regulatory compliance. We provide end-to-end safety solutions from case processing to aggregate report preparation, supporting your products throughout their lifecycle.
Our certified pharmacovigilance professionals maintain continuous safety surveillance, ensuring patient safety and regulatory compliance across global markets.
We utilize advanced safety databases and signal detection algorithms to proactively identify potential safety concerns. Our team stays current with evolving regulatory requirements from FDA, EMA, PMDA, and other global health authorities. We provide 24/7 safety monitoring, medical review, and risk management support to help you maintain compliance and protect patient safety while optimizing your pharmacovigilance operations.
Frequently Asked Questions
Q: What safety databases do you support?
A: We support all major safety databases including Argus, ARISg, Veeva Vault Safety, and our proprietary eAnalytics Safety Sentinel platform. Our team is certified in multiple systems and can work with your existing safety database or implement our advanced solution.
Q: How do you ensure regulatory compliance?
A: Our pharmacovigilance team includes regulatory experts who monitor global requirements from FDA, EMA, MHRA, Health Canada, and other authorities. We implement robust quality management systems, conduct regular audits, and maintain comprehensive SOPs to ensure full compliance with ICH E2 guidelines and local regulations.
Q: Do you provide signal detection services?
A: Yes, we offer comprehensive signal detection and management services using both qualitative and quantitative methods. Our team utilizes advanced analytics, disproportionality analysis, and medical review to identify, validate, and manage safety signals in accordance with regulatory expectations.
Our Pharmacovigilance Services Include
- Case processing and management
- Medical coding (MedDRA, WHO-DD)
- Quality review and reconciliation
- Signal detection and management
- Risk management plan development
- Periodic safety update reports (PSURs)
- Risk evaluation and mitigation strategies (REMS)
- Safety database migration and validation
