Individual Case Safety Report (ICSR) case processing is a critical component of pharmacovigilance, ensuring the collection, assessment, and reporting of adverse events related to medicinal products. Melior life sciences (MLS) offers comprehensive ICSR case processing services to assist pharmaceutical companies in maintaining compliance with global regulatory requirements.
With the changing landscape of product types and regulatory requirements, the quality of case processing of the information received from various sources such as clinical trial information, spontaneous, literature, legal, social media, regulatory authority, license partner cases are crucial for the analysis of risk-benefit profile and the safe and effective use of the product.
As an end-to-end pharmacovigilance service provider, we have the expertise in monitoring the regulatory landscape. We have the systems in place to continually assess the impact of changing regulations on existing processes to ensure regulatory compliance and inspection readiness.
Pharmacovigilance Our pharmacovigilance operating model offers the choice of best-in-class databases coupled with in-house scientific expertise to deliver high-quality compliance, which is scalable, secure, and technology-driven.
As a part of our approach, our customers will choose the safety database, which integrates best with their preferences. These safety platforms that MLS offers are backed by robust validation, assured infrastructure, certifications, security, and quality.
| © 2024 All rights reserved |