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 pharmcovigilance 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 of Pharmacovigilance System Master File (PSMF)
- Safety Data Exhange Agreement (SDEA) Preparation & 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)
- Product Complaints Management & Reporting
- Adverse Events case Processing & Reporting
- Safety Reconciliation
- Signal Management
- Eudravigilance Registration & Management
- Regulatory Intelligence, 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 / product complaints
- 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 solutions.
