Pharmacovigilance Services in Turkey

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Turkey, explore DDReg pharmacovigilance services in Turkey for ensuring drug safety and regulatory compliance. From adverse drug reaction (ADR) reporting to compliance with TUFAM pharmacovigilance regulations, the right local pharmacovigilance partner in Turkey drives efficient signal detection, risk management planning, safety reporting, and successful market authorization.

DDReg is a trusted local pharmacovigilance partner in Turkey, offering end-to-end PV services Turkey that ensure compliance with TUFAM regulations. Our team provides tailored pharmacovigilance consulting Turkey, delivering risk mitigation, regulatory intelligence, and strategic safety solutions across all stages of a product’s lifecycle.

We specialize in drug safety solutions in Turkey, including PV outsourcing Turkey, aggregate reporting, signal detection, risk management planning, and support for compliance audits. Our services enable pharmaceutical companies to streamline PV operations while meeting local regulatory requirements.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3)-compliant databases integrated with WHO Drug Dictionary (WHO DD) and MedDRA
  • Quality check and medical reviews
  • Submission of cases per agency timelines
  • Maintenance of ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information; preparation of reports recommending mitigation methods
  • Implementation of supplementary measures including Post-Authorization Safety Studies (PASS )
  • Conveying risks effectively through labeling documents such as SmPC and Patient Information Leaflets (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs )
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
  • Periodic Benefit-Risk Evaluation Reports ( PBRERs)
• + Signal Management
  • Identification of new safety signals from ICSRs, literature, regulatory websites, and aggregate reports
  • Signal detection and tracking using in-house databases and tools
  • Review of safety signals and recommendations from pharmacovigilance risk assessment committees
  • Label update analysis and risk minimization strategy recommendations
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + Local Pharmacovigilance Services in turkey
  • Appointment of Local Pharmacovigilance Officer (Equivalent to QPPV)
  • Review of Pharmacovigilance System Master File (PSMF ), SDEAs, agreements with commercial partners, and PV SOPs
  • Retainer services for QPPV and Deputy QPPV
  • Local safety responsible, monthly reconciliation, and medical review of signal detection
  • Quarterly Signal Surveillance Meetings and monthly compliance reporting
• + PV Quality Management & Compliance
  • Review and optimize audit plans and mock audits for PV inspections by TUFAM
  • Conduct regular gap assessments of PV staff
  • Organizational training on safety audits and inspections
  • Ensure compliance with PV guidelines, regulations, SDEAs, SOPs, and work instructions