Pharmacovigilance and Materiovigilance Services

“Keeping it safe and risk-free”, is a notion that’s always on the top of your wish list whenever you introduce a newly emerged product or medical device to the market. Our job is to turn it from a wish into an actual action plan! Through the years, our team has developed CEUTICO’s QPPV/LSR until they fully acquired adequate theoretical and practical knowledge for all the Pharmacovigilance and Materiovigilance activities. The teams are completely aware of all Pharmacovigilance, quality systems, and the medicinal products covered by the Pharmacovigilance system. They are also aware of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products. The bottom line, such awareness is empowering us to make the most suitable vigilance and post-marketing decisions and procedures to tailor for your product/device needs!

CEUTICO Pharmacovigilance Outsourcing Services Includes:


  • Full Pharmacovigilance activities
  • Pharmacovigilance Master File Development & Maintenance
  • Developing Standard Operating Procedures 
  • Establishing Quality Management System
  • Auditing Services & PV Inspection readiness
    • Independent pharmacovigilance auditing (through our independent auditing team)
    • Quality management system development (procedures, training, compliance, and quality)
    • Strategic and tactical audit planning and risk assessment
    • Audit and inspection preparation
    • Inspection readiness.
  • Development of Risk Management Plan (RMP)
  • Development of Periodic Benefit Risk Assessment Reports (PBRER)
  • Literature Search 
  • Creating Submission of Individual Case Safety Reports (ICSRs)
  • Signal Management Procedure (detection, validation, prioritization, and evaluation)
  • Developing & Reviewing Safety Data Exchange Agreement (SDEA) with 3rd party
  • Training the Sales team on the reporting process
  • Follow up post-authorization safety studies with CROs
  • Develop additional risk minimization measures “Direct Health Care Professional Communication (DHPC), Educational Materials..etc” when needed
  • Evaluating risk minimization measures effectiveness
  • Evaluating PV system performance

CEUTICO Materiovigilance Outsourcing Services Includes:


  • Set up and maintain of complete medical device vigilance system, for all types of devices
  • Writing and/or review Standard Operating Procedures
  • Literature search and review
    Preparation of;
    • Trend Reports (TRs)
    • Periodic summary reports (PSRs)
    • Periodic Safety Update Reports (PSURs)
    • Incident & user Error Reports
  • Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSNs)
  • Storage and protection of medical device incidents records
  • Training Sales Team on Reporting Process