Quality Services
Quality in pharmacovigilance is a key fundamental requirement to ensure a robust and compliant PV System is in place which complies with regulatory requirements and more importantly ensure patient safety. As such, McMahon Pharma Consulting Ltd. can provide support with;
- Auditing
- Inspection readiness: Support pre, during and post inspection
- Procedural document preparation: Standard Operating Procedures (SOPs), Working Instructions and guidance documents
- Training
Operational Services
- Pharmacovigilance system set-up
- Gap analysis/system improvement/system efficiency
- Pharmacovigilance System Master File (PSMF)
- EudraVigilance inc. XEVMPD
- Aggregate report writing (PSURs, PBRER, DSURs, PADER)
- Safety database support: upgrades, user manuals
- Safety Data Exchange Agreements (SDEAs)
- Training