VIGILLANCE

Patients' safety and well-being are paramount for your product’s safety profile and overall effectiveness thus encompasses every aspect of our vigilance activity.

At CORONIS we comprehend that the safety of your product is of primary concern. Thus we ensure the advanced quality of our Vigilance services in order to respond exceptionally, even to the highest demands.

In full compliance with the National and European Legislation on medicinal products, medical devices and cosmetics, our Vigilance experts provide excellent consultation services while, giving you a great insight to your vigilance strategy planning.

Pharmacovigilance services:

  • 24/7 availability of Local QPPV and Deputy Local QPPV
  • Development and maintenance pf Pharmacovigilance System Master File (PSMF)
  • SDEAs Management (safety plan and workflow mapping)
  • Management of Individual Case Safety Reports (ICSRs)
  • Development of Periodic Safety Update Report (PSUR)
  • Development Safety Update Report (DSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Registrations in Eudravigilance
  • Regulatory compliance and consulting
  • Pharmacovigilance Training
  • Scientific Literature Surveillance and monthly reporting
  • Support on the compilation of the Standard Operating Procedures (SOPs)
  • Audit and inspection readiness

Medical device vigilance services:

  • Management and reporting of medical device adverse incidents / use errors
  • Preparation of Field Safety Notice (FSN)
  • Management of Field Safety Corrective Action (FSCA) reporting process

Cosmetovigilance services:

  • Management and assessment of adverse effects of cosmetics reported by consumers, health professionals or authorities
  • Verification and reviewing of serious unexpected events (SUE) and submission to the authorities
  • Periodic literature search to identify safety information and adverse events of cosmetic products

Contact us today to learn more about our vigilance services

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