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

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ceutico consulting services

  • EG
  • 2024
    On CPHI since
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Regulatory Affairs
View company profile
Categories
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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

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

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