Your Partner in Pharmacovigilance Compliance
Regulatory authorities such as the FDA, Health Canada, TGA, and EMA mandate pharmacovigilance (PV) or the collection, detection, assessment, monitoring, reporting, and prevention of adverse effects with drugs and medical devices. Together with our partners, AXSource supports our clients in ensuring compliance with post-marketing procedures.
AXSource supports the following pharmacovigilance services:
Compliance Documentation
- Pharmacovigilance system procedures and implementation of Standard Operating Procedures (SOPs).
- Preparation/review of technical and PV agreements.
- PV software system validation.
Safety Reporting to Regulatory Agencies
- Individual Case Safety Reports (ICSRs).
- Issue-Related Summary Reports (IRSRs).
- Annual summary reports in ICH and non-ICH formats, including PSURs, PBRERs, and PADERs.
Regulatory Inspection & Audit Support
- Self-inspection support.
- Compliance gap analysis audits.
- Preparation & hosting of GVP inspections.
- Corrective action and preventive actions.
- Good Pharmacovigilance Practices (GVP).
