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

IGRS provides complete support for creations of tandard perating rocedures (SOPs) for all pharmacovigilance processes including Adverse Events (AE) Reporting; Aggregate eporting; Pharmacovigilance iterature earch; Pre-preparation and submission of ggregate eports; Safety ignal etection; Risk anagement; uality ontrol; ecord anagement and rchival; udits and nspections.

 

The services provided are as follows:

  • IGRS shall provide Master List of SOPs, these SOPs are written to meet national and international requirements.

  • Preparation, review, maintenance and updates of Standard Operating Procedure (SOPs) for pharmacovigilance activities

  • Preparation, review, maintenance and updates of Training documents for the pharmacovigilance to executives, customer’s staff, on field agents and other key players.

  • Preparations of Audit plans and conductance of GVP compliant Internal Audits as per the Global regulatory norms

  • Through due diligence of SOPs time to time updates to meet current regulations, audits and inspections.

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