PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Liberia’s Modernizing Market: LMHRA | WAHO | ICH | GVP
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical and health product sectors in the Republic of Liberia.
Liberia is undergoing a transformative period in pharmaceutical regulation. As of January 2025, the LMHRA officially launched its Service Delivery Charter, setting clear performance standards for drug registration and safety oversight. Furthermore, in September 2025, Liberia hosted its first groundbreaking international conference on Pharmacovigilance and Clinical Trials, signaling a rigorous new era of "Safety Monitoring in Emerging Regulatory Systems." Since 2008, we have supported firms in delivering dossiers that satisfy the LMHRA’s mandate to protect the Liberian populace from substandard and unsafe medicines.
Who We Support in Liberia
We provide specialized pharmacovigilance expertise across Liberia’s regulatory landscape:
International Pharmaceutical Exporters: Managing PBRER cycles for medicines registered via the WAHO/ECOWAS harmonized procedure, ensuring 100% compliance with Module 5.3.6 of the CTD.
Local Responsible Persons (LRP): Providing technical back-end support to Liberia-based representatives who are legally mandated to manage safety data and authority queries.
Generic Drug Manufacturers: Navigating the strict 2025 requirements for Bioequivalence standards and safety monitoring for generic products entering the Liberian market.
Public Health Programs (NACP/NMCP): Assisting with the safety documentation required for anti-malarials and specialized medicines distributed through national health initiatives.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) for studies conducted under the oversight of the National Research Ethics Board (NREB).
Our PSUR & PBRER Services
Our scientific precision aligns with the LMHRA’s commitment to scientific discovery and proactive patient safety:
ECOWAS-CTD Compliant PBRERs: Expert drafting in the ICH E2C (R2) format, ensuring seamless integration into the harmonized registration dossiers used across West Africa.
"Service Charter" Alignment: We optimize our report delivery timelines to match the LMHRA’s new 2025 efficiency standards, facilitating faster renewals and variations.
Benefit-Risk Synthesis: High-level medical evaluations that justify the continued use of products within the Liberian clinical context, particularly for medicines targeting endemic diseases.
Local Signal Detection: Utilizing scientific methodologies to validate safety signals, incorporating data from the National Pharmacovigilance Center (NPC) and global platforms like VigiBase.
Risk Management Plan (RMP) Support: Developing strategies to mitigate identified risks, a key priority following the September 2025 Joint GVP Inspections in Liberia.
Why Pharma Leaders in Liberia Choose PSUR Central
"Scientific rigor to navigate Liberia’s ambitious and harmonized regulatory future."
2025 Regulatory Intelligence: We are fully operational under the latest LMHRA Service Delivery Charter and the 2025 Clinical Trial Regulations, ensuring no delays in your product lifecycle.
Inspection Readiness: Following Liberia’s first Joint GVP Inspection (Sept 2025), we provide the "Audit-Ready" safety dossiers needed to survive high-stringency regulatory scrutiny.
WAHO Regional Excellence: Our reports are designed for the West African Health Organization standards, facilitating cross-border compliance for firms operating throughout the ECOWAS region.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
LMHRA Act of 2010: The foundational law for medicines and health products in Liberia.
Guidelines for Pharmacovigilance System in Liberia (2022/2025 Updates): The national framework for ADR reporting and safety monitoring.
ECOWAS Common Technical Document (CTD) Protocol: The harmonized regional standard for dossier submission.
ICH E2C (R2): The international gold standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Liberia, we typically require:
Product Portfolio and registration status (National or WAHO Regional).
Local Responsible Person (LRP) Details: Coordination info for your authorized Liberian agent.
Approved Labeling: The SmPC and Patient Leaflet in English (mandatory for LMHRA).
Local Safety Data: Summary of ICSRs reported via the LMHRA Red Form or your global database.
Submission Timeline: Coordination with your 5-year registration validity or 12-month renewal window.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Liberia is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.