Pharmacovigilance
The primary goal of regulatory bodies overseeing drug development and commercialization is to ensure public safety. Pharmacovigilance plays a crucial role in this by promoting the safe and effective use of pharmaceuticals. Successful product development hinges on several factors, including a robust safety and efficacy portfolio, high-quality clinical data, effective regulatory strategies, and timely submissions throughout the approval process. Once a drug is approved, implementing effective risk mitigation strategies and pharmacovigilance processes is essential to comply with both regional and global regulations. Non-compliance can lead to serious repercussions. Therefore, partnering with experts proficient in navigating complex global regulatory landscapes is vital for maintaining inspection readiness and ensuring the safe and effective use of therapeutic products.
Individual Case Safety Report (ICSR) Case Processing
The quality of ICSR case processing impacts the risk–benefit profile and safe usage of the medicinal product
Given the evolving landscape of product types and regulatory requirements, the quality of case processing is critical. This includes handling information from diverse sources such as clinical trials, spontaneous reports, literature, legal cases, social media, regulatory authorities, and license partners. Accurate case processing is essential for assessing the risk-benefit profile and ensuring the safe and effective use of the product.
SentinelRX processes and systems help in
As a full-service pharmacovigilance provider, we specialize in navigating the complex regulatory landscape. Our advanced systems are designed to continuously evaluate the effects of evolving regulations on our processes, ensuring ongoing compliance and readiness for inspections.
Our expertise across product types includes:
Integrated Pharmacovigilance Services
Our pharmacovigilance operating model provides access to top-tier databases combined with our in-house scientific expertise, ensuring high-quality, scalable, secure, and technology-driven compliance.
Clients can select from leading safety databases (Clinevo, AB Cube, PvEdge, Argus, & ARISg) that best meet their needs. Each safety platform offered by SentinelRX is supported by rigorous validation, reliable infrastructure, and robust certifications to guarantee security and quality.