Empower Your Product Journey with X Pharma Plus Regulatory Pharmacovigilance (PV)
Minimize risk and maximize trust with X Pharma Plus’s robust Pharmacovigilance (PV) solutions. We ensure patient safety while enabling life sciences companies to navigate complex Regulatory requirements with precision, compliance, and global expertise.
Regulatory Pharmacovigilance (PV) Services – Overview
Pharmacovigilance is a critical function in life sciences, encompassing drug safety, efficacy, and patient protection.
X Pharma Plus provides end-to-end PV services, covering operations, surveillance, databases, and Qualified Person for Pharmacovigilance (QPPV) responsibilities.
Outsourcing PV to a specialized partner helps companies:
- Manage unpredictable workloads cost-effectively
- Focus internal resources on strategic initiatives
- Ensure compliance, continuity, and reliability across jurisdictions
Our team has extensive experience in providing comprehensive, Regulatory-compliant PV solutions aligned with global requirements (EU, US FDA, India CDSCO/PvPI/DCGI) and other regional authorities.
Literature Monitoring
Continuous surveillance of indexed and grey literature for early detection and assessment of safety signals.
Individual Case Safety Report (ICSR) Management
End-to-end management of case lifecycle—from receipt and triage to medical review, quality control, and regulatory submission.
Aggregate Reporting
Preparation and submission of PADER, PBRER/PSUR, ASR/IRSR, and device-specific safety reports.
Risk Management Pharmacovigilance
Development, implementation, and maintenance of RMPs, REMS, and RMMs tailored to product and regional requirements.
Signal Detection Management
Structured detection, validation, prioritization, and tracking of safety signals per GVP Module IX.
Audit Support & Training Compliance
Comprehensive internal audit support, CAPA implementation, KPI tracking, and deviation handling.
Quality Assurance & Analysis
Ensuring compliance, data integrity, and efficiency across PV systems and processes.
Safety Regulatory Intelligence
Monitoring and evaluation of evolving pharmacovigilance regulations and requirements.
Regulatory Pharmacovigilance (PV)
Services
“Comprehensive monitoring, evaluation, and reporting of drug safety data to ensure regulatory compliance and maintain patient safety throughout the product lifecycle.”
Here’s what each acronym means:
- PSUR (Periodic Safety Update Report): A report summarizing global safety data for a marketed product, typically required by the EMA.
- PBRER (Periodic Benefit-Risk Evaluation Report): A harmonized ICH-format report combining safety and benefit-risk assessment (replaces PSUR in many regions).
- DSUR (Development Safety Update Report): An annual safety report for products under clinical development (pre-approval phase).
- PADER (Periodic Adverse Drug Experience Report): The U.S. FDA’s equivalent of post-marketing safety reports for approved drugs.
- ASR (Annual Safety Report): A yearly safety summary for ongoing clinical trials.
- RMP (Risk Management Plan): A detailed plan outlining how identified and potential risks will be minimized or managed throughout the product lifecycle.
- REMS (Risk Evaluation and Mitigation Strategy): A U.S. FDA-mandated program ensuring benefits of a drug outweigh its risks through specific safety measures.