PV outsourcing services
Comprehensive Pharmacovigilance Services for Egypt & the Arab RegionAs a leading Egyptian pharmacovigilance partner, we provide end-to-end drug safety and regulatory compliance solutions specifically designed for the Egyptian Drug Authority (EDA) and Arab regional guidelines. Our services ensure your products meet all local regulatory obligations while safeguarding patient safety.
Our specialized services include
- Pharmacovigilance System Management & Audits:
We design, implement, and audit robust PV systems. This includes the development, maintenance, and readiness of your Pharmacovigilance Master File (PSMF) for EDA
2. Regulatory Agreement & Documentation:
Drafting, negotiation, and management of Safety Data Exchange Agreements (SDEAs) with partners, ensuring clear roles, responsibilities, and compliant data flow as per regional requirements.
- Full Adverse Event Case Handling:
End-to-end management of Individual Case Safety Reports (ICSRs) from collection through to submission to the EDA and other Arab health authorities.
2.PV Files Preparation and submission:
Preparation and submission of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other mandated PV and safety documents.
- Signal Detection & Risk Management:
Proactive safety surveillance, signal validation, and implementation of risk minimization strategies aligned with regional expectations.
2.Literature screening :
Provide weekly literature screening on global and local reference and regulatory sites.
Follow up safety issues and Direct Healthcare professional communications.
G)Local QPPV & Liaison Services:
Provision of a qualified Local Pharmacovigilance Responsible Person to act as your official contact with the EDA and Arab regulatory Authorities.
Our goal is to empower your market success in Egypt and the Arab region by ensuring unwavering compliance, proactive risk management, and complete patient safety.
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