McMahon Pharma Consulting Ltd.

Services

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