Your expert in vigilance
Vigilance & Post-Market Surveillance for All Healthcare Products
Ensuring the Safety, Compliance and Operational Continuity of Your Health Products
Whether dealing with medicinal products, medical devices, dietary supplements or digital health solutions, vigilance is a key regulatory obligation. It enables the early detection of potential risks, protects users and ensures the long-term sustainability of your products on the market.
BluePharm supports laboratories, start-ups, manufacturers and innovative companies in structuring, outsourcing or strengthening their vigilance systems in compliance with applicable regulations (pharmacovigilance, materiovigilance, digital vigilance, etc.).
Our approach is pragmatic, efficient and tailored to small and mid-sized organisations that do not always have the resources to build a dedicated vigilance unit internally.
Implementation or Optimization of Your Vigilance System
- Creation or update of vigilance procedures (pharmacovigilance, medical device vigilance, digital vigilance)
- Risk assessment and integration into the Quality Management System (QMS)
- Case intake, qualification, triage and documentation processes
- Regulatory compliance with relevant authorities (ANSM, EMA, DGCCRF, etc.)
Operational Management of Cases and Complaints
- Centralised intake of user feedback
- Case qualification, coding and medical assessment where required
- Management of incidents, adverse events and non-conformities
- Regulatory reporting to the competent authorities
- Management of corrective actions (CAPA) in coordination with the Quality Management System
Post-Marketing Surveillance & Periodic Reports
- Continuous monitoring of safety and performance
- Statistical trending and early signal detection
- Regulatory reports according to product categories:
PSUR / DSUR (drugs)
PMS / PSUR (medical devices)
- Safety assessments for digital health solution
- Regular safety review meetings (monthly / quarterly)
Audit and Inspection Support
Preparation for internal and external audits
Preparation for inspections by the ANSM and notified bodies
Review of vigilance procedures and case documentation
Post-audit remediation and implementation of corrective actions
Subscription Plan
- Full case management (incidents, adverse events, complaints)
- Quarterly trending and signal monitoring
- One PSUR / PMS report and quarterly safety review meetings
- Continuous regulatory support
