Explore our well-established, end-to-end pharmacovigilance services, tailored to ensure compliance with the SFDA. From local QPPV hosting and system setup to inspection support, audits, and local Saudi safety reporting, our expert team ensures that your PV operations are fully aligned, audit-ready, and seamlessly integrated with your global systems, allowing you to focus on patient safety while we handle compliance.
SFDA Inspected
EU Audited
ISO Certified
Well-Established
On-Ground Expertise
Local QPPV Service
We act as your designated Local QPPV in Saudi Arabia, as required by SFDA pharmacovigilance guidelines. Our service includes complete coverage of all local PV obligations, supported by a Saudi-licensed pharmacist as the official QPPV and a deputy QPPV to ensure continuity.
- Appointment of certified Saudi QPPV and deputy QPPV
- Integration with your global PV team and systems
- Oversight of all local safety submissions and compliance activities
- SFDA PSSF and PMSF management
- 24/7 availability and authority engagement
We ensure your pharmacovigilance operations in Saudi Arabia remain fully compliant, with experienced professionals managing everything from local literature to case follow-up.
Build Your PV Foundation
Pharmacovigilance Systems
We develop complete SFDA-compliant pharmacovigilance systems for companies entering the Saudi market. This includes building all required documentation, SOPs, and safety workflows from the ground up, tailored to your organizational needs.
- Creation of Saudi Pharmacovigilance System Master File (PMSF)
- Development of Pharmacovigilance Sub-System File (PSSF)
- Design of local PV procedures and safety reporting process
- Staff training on Saudi PV operations and SFDA expectations
- Integration with global safety systems and data flow
Our team ensures that your PV system meets local and global standards, while preparing your team to run operations independently.
Navigate Inspections with Confidence
Inspection Support
We support companies preparing for SFDA PV inspections and assist in closing inspection findings. Our approach ensures readiness through structured assessments, training, and the planning of corrective actions.
- Mock inspection and gap analysis
- Team coaching on SFDA inspection procedures
- CAPA drafting, execution, and follow-up
- Documentation review and response preparation
- Post-inspection support until closure
We help minimize inspection risks and ensure your pharmacovigilance system meets SFDA’s Good Pharmacovigilance Practices (GVP) requirements.
Clear Insights, Stronger Systems
Pharmacovigilance Audit
We perform annual internal audits of local pharmacovigilance systems to ensure alignment with SFDA GVP guidelines. These audits promote proactive compliance and system improvement.
- Comprehensive audits for compliance with SFDA expectations
- Educational audits with live feedback and PV team engagement
- Actionable audit reports and risk-ranking of findings
- Follow-up support for CAPA planning
- Optional third-party or distributor audits
We help clients turn audits into learning opportunities, strengthening both systems and teams.
Global Data, Local Compliance
Localization & Execution
We adapt and execute core pharmacovigilance activities to align with Saudi SFDA regulatory requirements, ensuring accuracy, completeness, and proper formatting of safety documents.
- Localization of Risk Management Plans (RMPs) in SFDA annex format
- Local PSUR preparation and submission
- Support for signal detection reports and justification
- Implementation of Risk Minimization Measures (RMM)
- Authority-compliant safety submissions
Our local expertise ensures that your global documents are translated into SFDA-ready formats, improving acceptance and reducing the need for back-and-forth communication with regulators.
Weekly Screening, Zero Gaps
Local Literature Monitoring
We provide weekly local literature screening services, ideal for companies whose staff is overwhelmed by other PV activities, thereby eliminating the need for time-consuming routine monitoring. We ensure compliance with SFDA’s requirement for continuous local data surveillance.
- Weekly screening of Saudi-based scientific journals
- Documentation and archiving of all search results
- Identification of safety signals or ICSRs
- Integration with your global case management process
- QPPV briefing reports and authority-ready documentation
This service reduces internal burden while maintaining compliance with local reporting timelines.
SOPs Built for Compliance
Pharmacovigilance Quality System
We design and implement quality systems specific to local pharmacovigilance operations in Saudi Arabia, ensuring documentation and processes meet SFDA standards.
- Establishment of PV-specific Quality Management Systems (QMS)
- Development of local PV SOPs aligned with global frameworks
- Custom workflows for adverse event management
- Audit readiness and document control processes
- Ongoing SOP updates as regulations evolve
We align operational quality with regulatory expectations to build a reliable, inspection-ready PV environment.
Knowledge that Drives Readiness
Pharmacovigilance Training
We provide targeted pharmacovigilance training for local teams, QPPVs, and distributors in Saudi Arabia. We tailored our training to meet the SFDA expectations and to address practical case handling.
- QPPV onboarding and responsibilities training
- Custom PV training modules for staff and partners
- Case handling workshops and hands-on exercises
- SFDA-focused regulatory training
- Mock inspection interview preparation
Our training helps your team understand not just what to do but also how and why, building confidence and compliance.
Local Safety, Global Sync
Clinical Trials & PSP Support
We support companies conducting Patient Support Programs (PSPs) or Clinical Trials in Saudi Arabia by managing local safety reporting requirements and integration with global safety systems.
- Set up of local case intake channels for PSPs and trials
- Case processing and reconciliation within sponsor systems
- Support in SAE/AE reporting per SFDA timelines
- PV training for program staff or site monitors
- Regulatory submission of relevant safety reports
We seamlessly integrate with your global teams to ensure local compliance, data quality, and timely reporting to SFDA.