Pharmacovigilance

Pharmacovigilance
Product Description

We provide full pharmacovigilance services to your company

  • Full Pharmacovigilance activities
  • Pharmacovigilance Master File Development & Maintenance
  • Developing Standard Operating Procedures 
  • Establishing Quality Management System
  • Auditing Services & PV 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 Developing 
  • Reviewing Safety Data Exchange Agreement (SDEA)
  • Training the Sales team on the reporting process
  • Follow up post-authorization safety studies with CROs 
  • creating eductaional materials and any other additional risk minimisation measures

Read more Show less

ceutico consulting services

  • Country/Region:
    Egypt
  • On CPHI since:
    2024
  • Employees:
    1 - 24
Company types
Contract Research Organisation (CRO)
Primary activities
Regulatory Affairs
View company profile
Categories
more categories Show less
Specifications
  • Details
    • Full Pharmacovigilance activities
    • Pharmacovigilance Master File Development & Maintenance
    • Developing Standard Operating Procedures 
    • Establishing Quality Management System
    • Auditing Services & PV 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 Developing 
    • Reviewing Safety Data Exchange Agreement (SDEA)
    • Training the Sales team on the reporting process
    • Follow up post-authorization safety studies with CROs 
    • creating eductaional materials and any other additional risk minimisation measures
  • Selling Points
    Price; Product Performance; Quality Service; Reputation; Sustainability
  • Supplied from
    Egypt
More specifications Fewer specifications
Sales Markets
Show more Show less

ceutico consulting services

  • Country/Region:
    Egypt
  • On CPHI since:
    2024
  • Employees:
    1 - 24
Company types
Contract Research Organisation (CRO)
Primary activities
Regulatory Affairs
View company profile

More Products from ceutico consulting services (1)

  • REGULATORY AFFAIRS SERVICES

    Product REGULATORY AFFAIRS SERVICES

    Prepare regulatory dossiers in either CTD or NeeS formatFulfill all regulatory procedures till getting a product license 
     Prepare separate files ready for submission in different regulatory steps
    Prepare scientific files
    Prepare product labelling data
    Prepare product leaflets  q...