PHARMACOVIGILANCE

Microsoft Dynamics ERP For Quality and Compliance

Regulatory authorities such as Health Canada and FDA mandate pharmacovigilance (PV) or the collection, detection, assessment, monitoring, reporting and prevention of adverse effects with drugs and medical devices.

AXSource Consulting supports the health care industry in the following PV areas:

  • Pharmacovigilance System Design
  • Pharmacovigilance Training – Clinical Trial and Post Market Serious Adverse Event / Medical Device Problem Reporting
  • Audit Support
  • Annual Summary Report, PSUR, PBRER
  • Health Care Professional Letters / Public Advisories
  • Product Risk Assessment & Mitigation Strategies
  • Risk Management Plans (RMP)