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Our Services

IGRS Pharmacovigilance offers a comprehensive range of services to pharmaceutical companies, ensuring compliance with regulatory requirements and promoting the safety of medicinal products. At IGRS Pharmacovigilance, we are committed to providing efficient and compliant pharmacovigilance solutions, enabling companies to maintain the highest standards of drug safety and regulatory compliance.

EU Services

  • Set-Up of Pharmacovigilance System Master File (PSMF)

  • Appointment of the Qualified Person for Pharmacovigilance

  • Local PV system set-up and nomination of Local Persons for PV (LPPVs)

  • EudraVigilance services

  • Managing Pharmacovigilance Data Migration

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Pharmacovigilance System and Quality Control

  • Consultations on Pharmacovigilance System implementation

  • Standard Operating Procedures (SOPs) management for pharmacovigilance process and quality system aspects

  • Preparation for ‘mock’ audits and recommended corrective and preventive action (CAPA)

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Global Services

  • Safety Database

  • Individual Case Safety Report (ICSR) Services

  • Aggregate reporting

  • Pharmacovigilance literature search

  • Safety signal detection services

  • Risk Management Services

  • Regulatory Intelligence

  • Ongoing Monitoring Services

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