Overview

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. 

 

Freyr Expertise

  • PV database & system setup and strategic services
  • Aggregate report services/periodic safety report services
  • ICSR services
  • Signal detection
  • Literature monitoring services
 

Freyr Advantages

  • Single point of contact for the entire range of safety services including ICSR, Aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US Agent services, Signal Detection & Evaluation, database migration, adverse event reconciliation, and local affiliate services
  • Initial kick-off to submissions to HA and handling/addressing HA queries
  • In-depth safety knowledge perfectly integrated with required IT capabilities
  • Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
  • Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name few
  • Expertise in writing aggregate safety documents as per various health authority and submission requirements like Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
  • Expertise in setting up PV systems and processes, PV Database Evaluation, PV Database Validation, Harmonization, writing SOPs and training employees as per local Regulatory requirements in various geographies
  • Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
  • Extensive experience in PV process harmonization and creation of  Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
  • Experience in tracking safety variations and PV System Master File (PSMF) compliance
  • Defined processes of thorough scientific, medical, editorial and quality control review
  • Timely delivery with the highest standard of quality
  • Expert program and project management support to maintain compliance