Pharmaceutical & BioTech

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Discover all our Pharmacovigilance services

Drug Development Regulatory Affairs Market Access Pharmacovigilance Quality & Compliance Case Studies

Local Pharmacovigilance

ENSURING PATIENT SAFETY WITH LOCAL AND GLOBAL EXPERTISE

RPN offers a comprehensive range of Pharmacovigilance and Drug Safety solutions throughout the product life cycle. Our local and global expertise, combined with cutting-edge technology and compliance-driven practices, ensures comprehensive and reliable Pharmacovigilance solutions.

LOCAL QPPV & LOCAL SAFETY OFFICER (LSO)

Navigating the complex landscape of pharmacovigilance regulations in different countries can be challenging. That is why we provide Local Persons for Pharmacovigilance (LPPVs) and Local Safety Officers (LSOs) who have a deep understanding of local requirements, ensuring compliance and minimizing risks wherever a company’s products are distributed.

ICSR CASE MANAGEMENT

Managing Individual Case Safety Reports (ICSRs) is critical to maintaining safety standards. RPN handles end-to-end case processing for both non-interventional ICSRs and Clinical Trial Serious Adverse Events (SAEs) and other reportable adverse events. From data entry and quality control to regulatory submission and follow-up, we manage safety data efficiently and ensure compliance.

LITERATURE MONITORING

Patient safety is at the heart of our Literature Monitoring service. Our Global Literature Monitoring (GLM) and Local Literature Monitoring (LLM) enable early identification of safety issues and relevant clinical information. This proactive approach supports signal management and informs the benefit-risk profile of products, ultimately safeguarding patients.