Your Trusted Partner for Pharmacovigilance Support in Oman
Oman is emerging as a strategically important pharmaceutical market within the Gulf Cooperation Council (GCC), driven by healthcare modernization, regulatory strengthening, and increased focus on patient safety. However, entry into the Omani market requires more than product registration; it demands a robust, compliant, and inspection-ready pharmacovigilance system.
The Sultanate has significantly strengthened its drug safety framework in recent years, introducing structured pharmacovigilance obligations aligned with global standards. For pharmaceutical companies, this creates both opportunity and operational complexity.
At DDReg, we deliver end-to-end pharmacovigilance services in Oman, enabling companies to meet regulatory expectations, ensure patient safety, and maintain full lifecycle compliance.
Pharmacovigilance Framework in Oman
Pharmacovigilance in Oman is governed by the Ministry of Health (MoH) through the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) and the Drug Safety Center (DSC).
The Department of Pharmacovigilance and Drug Information (DPV&DI) functions as the national pharmacovigilance center, responsible for:
- Post-marketing surveillance of medicinal products
- Adverse drug reaction (ADR) collection and evaluation
- Safety communication and risk mitigation measures
Oman has been part of the WHO Programme for International Drug Monitoring since 1995 and operates a structured pharmacovigilance network across regional centers.
Key Regulatory Expectations in Oman
Pharmaceutical companies (Marketing Authorization Holders – MAHs) must:
- Establish a fully functional pharmacovigilance system
- Maintain a Pharmacovigilance System Master File (PSMF)
- Submit periodic safety reports (PSUR /PBRER)
- Conduct signal detection and risk management activities
- Ensure timely ADR reporting
- Be inspection-ready at all times
Additionally, MAHs are required to appoint a Qualified Person for Pharmacovigilance (QPPV) responsible for maintaining and overseeing the PV system.
This structured yet evolving system makes local expertise and compliance-driven execution essential.
Our Pharmacovigilance Services in Oman
DDReg provides comprehensive, scalable, and regulator-ready drug safety services in Oman, designed to align with both Omani regulations and global pharmacovigilance frameworks (ICH, EMA, WHO).
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Individual Case Safety Report (ICSR) Management
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Aggregate Reporting & Safety Writing
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Signal Detection & Risk Management
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Local Pharmacovigilance Compliance in Oman
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Literature Screening & Safety Intelligence
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Pharmacovigilance Consulting Services in Oman
Why Choose DDReg as Your Pharmacovigilance Company in Oman?
We understand Oman’s evolving pharmacovigilance landscape, including MoH expectations, GVP requirements, and GCC harmonization trends.
Our services align with:
- ICH Guidelines
- EMA Good Pharmacovigilance Practices (GVP)
- WHO Pharmacovigilance Standards
From clinical trials to post-marketing surveillance, we manage complete drug safety operations.
We build pharmacovigilance systems designed for:
- Regulatory audits
- Health authority inspections
- Continuous compliance
We leverage advanced safety databases and automation tools to improve accuracy, compliance, and turnaround time.
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Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
