Seamless Integration with Global Safety Operations

Pharmacovigilance Third-Party QPPV Solutions & Consulting Services

Explore our well-established end-to-end pharmacovigilance solutions tailored to provide compliance with SFDA. From local QPPV hosting and system setup to inspections support, audits, and local safety reporting, our expert team ensures your PV operations are fully aligned, audit-ready, and seamlessly integrated with your global systems—so you can focus on patient safety while we handle compliance.

SFDA Inspected
EU Audited
ISO Certified
Well-Established
Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

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 full 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 your PV system meets local and global standards while preparing your teams to run operations independently.

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia
Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

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 corrective action planning.

  • 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.

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia
Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

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 your global documents are translated into SFDA-ready formats, improving acceptance and reducing back-and-forth 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 for such 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.

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia
Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

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. Our sessions are tailored to SFDA expectations and 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.

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia
Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

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.

  • Setup 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.

Have Questions? Lets Connect..

Contact us to schedule a call, request details, or get a tailored proposal.