Extensive search and monitoring of international medical and scientific literature to identify safety signals and ensure regulatory compliance worldwide.
Analysis and summarization of relevant publications by experienced pharmacovigilance professionals for actionable insights.
Preparation of literature-based case reports and regulatory submissions in accordance with global requirements (EMA, FDA, etc.).
Early identification of potential safety issues through systematic literature review and signal management processes.
Tailored literature search protocols to meet the unique needs of each client and product portfolio.
Access to non-English sources and translation support for truly global pharmacovigilance coverage.
Robust quality control and documentation practices to ensure audit readiness and regulatory compliance.
Ongoing support and collaboration with client teams for seamless integration of literature search findings into safety processes.