Drug Safety, Pharmacovigilance Services, ICSR, FDA, PSUR

Drug Safety and Pharmacovigilance

Amid the periodic evolutions and amendments in safety monitoring regulations, maintaining the safety data of medicinal products/devices is the ultimate responsibility of Marketing Authorization Holder (MAH) to ensure the timely submissions of safety information to health authorities and renew the product registrations globally throughout the lifecycle of the medicinal products/devices in the market.

In a case where adverse events are reported, the process undergoes multiple steps including case triage/book-in, case processing, medical review, quality review and submission to Health Authorities (HAs) as Individual Case Study Reports (ICSR). The safety information is then pooled and evaluated as part of aggregate reports in the form of benefit-risk evaluation, signal evaluation, risk management, periodic safety reports, etc. Increased complexities, huge data, and evolving Regulatory standards have warranted the requirement of domain expertise on one side and huge cost involvement to maintain drug safety compliance on the other side. There arises a need of streamlined Pharmacovigilance (PV) services.

Freyr provides end-to-end PV services to guarantee optimal benefit-risk profile of the medicinal product with a goal to improve safety and achieve better patient outcomes. With a team of skilled and experienced safety and PV professionals (both medical and paramedical) from pharmaceutical and clinical research industry, Freyr demonstrates proven expertise in delivering high quality and compliant PV services for global large pharmaceutical and leading biotechnology companies of any size.