Pharmacovigilance Services in South Africa

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in South Africa, access DDReg’s pharmacovigilance and drug safety services in South Africa to ensure drug safety and regulatory compliance. From adverse drug reaction (ADR) reporting to risk management planning and signal detection, the right partner shapes everything from clinical research to post-marketing surveillance.

As a trusted pharmacovigilance consulting firm in South Africa, DDReg offers comprehensive pharmacovigilance consulting services in South Africa. We manage patient safety from clinical trials through post-marketing surveillance by delivering:

• Adverse drug reaction reporting
• Signal detection & management
• Aggregate report writing (PSURs , DSURs, ASRs)
• Customized pharmacovigilance plans/risk management plans (RMPs) aligned with local regulations and good pharmacovigilance practices (GVP)

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, including SUSARs
  • Case processing using E2B(R3)-compliant systems with WHO-DD and MedDRA
  • Quality checks and medical review, prompt submission per SAHPRA timelines
  • Ongoing ICSR monitoring, tracking, and customer reconciliation
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Creating tailored procedures to classify safety risks and recommend mitigation
  • Conducting Post-Authorization Safety Studies (PASS), educational materials, observational studies, and follow-up questionnaires
  • Communicating risks via Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PILs)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Detecting new or evolving safety signals from ICSR databases, literature, aggregate reports, and regulatory sources
  • Using in-house tools for signal detection and tracking
  • Reviewing signals with reference to PRAC recommendations, updating labeling as needed
  • Delivering recommendations and producing signal management trackers and annual reports
• + Local Pharmacovigilance Services in South Africa
  • Reviewing PSMF, Safety Data Exchange Agreements (SDEAs ), PV SOPs, etc.
  • Sign-off on aggregate reports, signal reports, and RMPs
  • Providing retainer-based services for QPPV or Deputy QPPV support and local safety responsibility
  • Monthly reconciliation, quarterly signal surveillance meetings, and compliance metrics reporting
• + PV Quality Management & Compliance
  • Conducting audits aligned with SAHPRA GVP guidelines, SDEAs, SOPs, and work instructions
  • Preparing audit plans and mock inspections to ensure readiness for SAHPRA inspections
  • Performing gap assessments and providing organizational training on PV audits and inspections