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SourcePHLEX

Post Market Product Maintenance

SourcePHLEX is the one-stop solution helping global pharma companies to manage their health authority obligations, in order to focus your own resource on the most strategic assets. Our trusted, flexible and quickly available local teams leverage their experience to reduce complexity by using innovative approaches to efficiently maintain your products. Our success is proven by long-term cooperation with our clients.
The services included within this bundle can include anything from development consulting, regulatory affairs, pharmacovigilance to quality and compliance. All services are tailored to your business needs.

Product Maintenance is the core of our maintenance offering:

  1. Portfolio maintenance outsourcing
  2. Merger & acquisition services
  3. Technical / medical writing & dossier updates
  4. 2nd wave submissions/ global roll outs
  5. Authority communication
  6. Classification of changes
  7. Dossier preparation, submissions & approvals
  8. eCTD Publishing all formats
  9. Labeling/PI/CCDs management globally
  10. Regulatory Intelligence
  11. Health Economic & Outcomes Research (HEOR)
  12. Rx to OTC Switch
  13. Aggregate report writing
  14. ICSR, signaling and risk management
  15. Pharmacoepidemiology
  16. VigiLit: literature surveillance
  17. EU-QPPV / Local-QPPV
  18. GxP Services
  19. Inspection Support & Remediation