PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Tongan market, the messaging highlights support for the Ministry of Health and the Health Preparations and Pharmaceutical Services, focusing on compliance with the Therapeutic Goods Act 2021 and international standards like WHO Prequalification and PIC/S.
PSUR Central – Global PSUR & PBRER Services
Ensuring Safety for Tonga’s Healthcare: MoH | WHO | PIC/S | ICH Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for pharmaceutical distributors, government agencies, and international suppliers operating in the Kingdom of Tonga.
As Tonga modernizes its regulatory framework under the Therapeutic Goods Act 2021, ensuring the safety and efficacy of imported medicines is a national priority. Based in the Pacific hub, we support organizations in Nuku'alofa to ensure that all safety documentation meets the clinical requirements of the Tonga Ministry of Health and aligns with the safety monitoring standards of the World Health Organization (WHO).
Who We Support in Tonga
We provide specialized pharmacovigilance expertise to the key stakeholders in the Tongan pharmaceutical supply chain:
Pharmaceutical Importers & Wholesalers: Managing safety reporting for essential medicines and generics to ensure continuous compliance with the Health Preparations and Pharmaceutical Services.
Public Health & Vaccine Programs: Providing aggregate safety summaries for vaccines and infectious disease treatments distributed under national health initiatives.
International Aid & NGO Partners: Ensuring that donated or subsidized medicinal products are accompanied by "authority-ready" global safety dossiers.
Regulatory Compliance Officers: Assisting local safety officers in synthesizing global safety data into reports suitable for review by the Tongan National Regulatory Authority.
Our PSUR & PBRER Services
We offer scientific excellence that supports Tonga's commitment to resilient and safe healthcare systems:
ICH E2C (R2) Compliant PBRERs: Professional drafting of the PBRER, the global standard for benefit-risk evaluation, tailored for products registered in Tonga.
WHO Prequalification Support: Ensuring safety documentation for essential medicines meets the high standards required for WHO Prequalified status.
Benefit-Risk Synthesis: Providing high-level medical evaluations that justify the continued safety profile of medicines within the Pacific context.
Signal Detection & Analysis: Utilizing global safety databases to monitor for signals that may impact the Tongan patient population.
Technical Gap Analysis: Auditing existing safety records to ensure they meet the modern requirements of the Therapeutic Goods Act 2021.
Why Partners in Tonga Choose PSUR Central
"Strengthening drug safety and regulatory compliance across the Pacific."
Regulatory Transition Experts: We understand the nuances of the 2021 Therapeutic Goods Act, helping you navigate the shift toward more structured pharmacovigilance.
Global Quality, Local Relevance: We provide the technical expertise of a global PV firm with an understanding of the specific supply chain challenges in the Pacific Islands.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically sound.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across WHO-aligned and PIC/S regulatory environments.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Therapeutic Goods Act 2021: The primary legislative framework for medicines in Tonga.
ICH E2C (R2): The global gold standard for periodic benefit-risk reporting.
WHO Good Pharmacovigilance Practices: The benchmark for safety monitoring in emerging and island regulatory systems.
PIC/S Standards: Ensuring alignment with international Pharmaceutical Inspection Co-operation Scheme guidelines.
Get Started: Partner With Us
To initiate a customized project for your Tongan-based operations or supply chain, we typically require:
Product Portfolio and the origin of the medicines (e.g., Australia, NZ, Fiji, India).
Approved Labeling: The Product Information or Package Insert used in the Tongan market.
Estimated Distribution Data: Units supplied to Tonga during the reporting period.
Summary of Global Safety Data: Any known safety updates or global regulatory actions.
Submission Deadlines: Per the requirements of the Ministry of Health.
Contact PSUR Central today to ensure your safety compliance in the Kingdom of Tonga is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready