Pharmacovigilance & Risk Management

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 pharmacovigilance services for health care industry in the following areas:

Pharmacovigilance System Design

Health Care Professional Letters / Public Advisories

Pharmacovigilance Training – Clinical Trial and Post Market Serious Adverse Event / Medical Device Problem Reporting

Product Risk Assessment & Mitigation Strategies

Audit Support

Risk Management Plans (RMP)

Annual Summary Report, PSUR, PBRER

Regulatory Inspection Support