Ensuring Regulatory Compliance: Managing Global and Local Literature Surveillance for Drugs and Medical Devices for a Leading Pharmaceutical Company
Managing Global and Local Literature Surveillance: Case Study Overview
Client Background
Our client, a leading pharmaceutical enterprise, required services regarding global and local literature surveillance in pharmacovigilance. This need arose from their limited in-house expertise, extensive worldwide authorizations, and numerous acquisitions.
Global and Local Literature Surveillance: Case Study Highlights
- APCER devised a holistic strategy that included the creation of sophisticated search strings, multilingual capabilities, stringent quality assurance protocols, and the development of local literature surveillance services.
- Starting with approximately 200 active molecules for global literature searches, and expanding the team as needed, APCER ensured robust literature surveillance and regulatory compliance.
- This case study underscores the critical role of customized solutions, effective communication, and client-focused project management in achieving 100% internal compliance and maintaining high-quality standards, thus ensuring readiness for regulatory inspections and operational efficiency through proficient global and local literature surveillance in pharmacovigilance.
APCER’s Literature Surveillance Capabilities:
Expert Team for Literature Surveillance
Our specialized healthcare professionals excel in leveraging advanced literature databases such as Embase and PubMed for thorough global literature surveillance in pharmacovigilance. They are adept at screening local journals for pertinent local literature surveillance.
Comprehensive Literature Monitoring Management
We are proficient in defining search strategies, conducting end-to-end literature searches and reviews, and providing medical literature monitoring and local literature screening services as per local regulations through an in-house expert team and strategic partners, along with procuring full-text articles.
Multilingual Capabilities in Pharmacovigilance
Enhance your global and local literature surveillance with our certified translators, who provide high-quality translations of literature articles to support comprehensive pharmacovigilance efforts across diverse regions.