Our Pharmacovigilance (PV) and Medical Affairs services ensure the safety, compliance, and scientific integrity of your products throughout their lifecycle. We provide comprehensive safety monitoring, case processing, and medical review solutions that help sponsors meet global regulatory requirements while protecting patient well-being.
Pharmacovigilance Services Include:
Case Processing & Reporting: End-to-end management of adverse event (AE) and serious adverse event (SAE) cases — from data entry and narrative writing to submission.
Safety Database Management: Setup, configuration, and maintenance of compliant safety databases (Argus, ARISg, or similar).
Signal Detection & Risk Management: Continuous monitoring and analysis to identify emerging safety signals and support proactive risk mitigation.
Periodic Safety Reports: Preparation of PSURs, PBRERs, DSURs, and other regulatory safety documents in accordance with ICH and regional guidelines.
Regulatory Compliance: Adherence to global pharmacovigilance regulations (FDA, EMA, Health Canada, MHRA, and others).
Medical Affairs Services Include:
Medical Review: Scientific and medical evaluation of safety data, narratives, and case reports.
Medical Writing: Development of high-quality documents including clinical study reports (CSRs), investigator brochures, and safety summaries.
Scientific Support: Assistance with literature reviews, publication planning, and response documents for regulatory queries.
Medical Information: Accurate and timely response to healthcare professional and patient inquiries.
With a focus on patient safety, regulatory compliance, and scientific excellence, our PV and Medical Affairs experts help sponsors maintain product integrity and public trust — from clinical development through post-marketing surveillance.
