Pharmacovigilance (PV) Services

Our pharmacovigilance solutions are designed to meet global regulatory standards while ensuring patient safety and data integrity throughout the product lifecycle. Our experienced team delivers end-to-end safety services across clinical trials and post-marketing surveillance.

Safety Database Proficiency

  • Expertise in leading safety platforms: Oracle Argus, ArisG, and other validated systems.
  • Advisory support for selection, configuration, and optimization of safety databases based on evolving needs.
Pharmacovigilance

Comprehensive Case Processing

End-to-end AE/SAE handling across:
  • Clinical trials (interventional & non-interventional)
  • Post-marketing surveillance
  • Solicited and unsolicited sources
Services include:
  • Data entry, MedDRA coding, narrative writing
  • Medical review & benefit-risk assessment
  • Query resolution, follow-up, and case closure
  • 100% Quality Control (QC) compliance

Regulatory Compliance & Reporting

  • Timely and compliant submission of:
    • ICSRs (CIOMS Forms)
    • DSURs / PSURs / PBRERs
    • Line Listings and Tabulated Reports
  • Submissions to: CDSCO, IRBs/ECs, global authorities
  • Compliance with ICH E2E/E2F guidelines and local requirements

Literature Surveillance

  • Dedicated literature experts conduct indexed and non-indexed journal reviews
  • Local PV representatives ensure regional compliance
  • Identification of ICSRs and emerging safety signals

Aggregate Safety Reporting

Preparation and submission of:
  • DSURs (Development Safety Update Reports)
  • PSURs/PBRERs (Periodic Safety Update Reports)
  • PADERs (Periodic Adverse Drug Experience Reports)
Services include:
  • Generation of line listings, narratives, and tabulations
  • Full report drafting, formatting, and submission
  • Management of authority feedback and follow-up

Key Performance Metrics

Commitment to client success through:
  • Rapid turnaround time (TAT)
  • Productivity & cost-efficiency
  • Regulatory alignment
  • High customer satisfaction
  • Transparent project tracking

Partner with Tupalin Research for flexible, efficient, and compliant pharmacovigilance support tailored to your development program.