PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Malta’s Pharmaceutical Hub: MMA | EMA | ICH | Windsor Framework
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for Malta’s thriving pharmaceutical and biotech community.
Malta is a key destination for global generic manufacturers and clinical research, offering a robust regulatory framework that bridges Southern Europe and beyond. As of January 2025, the regulatory landscape has evolved significantly with the full implementation of the Windsor Framework, affecting batch release and packaging for products moving through the UK. Additionally, with the EMA IRIS platform becoming mandatory for PSUR management, maintaining authority-ready safety dossiers is more critical than ever. Since 2008, we have supported Maltese Marketing Authorization Holders (MAHs) in navigating the Malta Medicines Authority (MMA) and EMA requirements with scientific precision.
Who We Support in Malta
We provide specialized pharmacovigilance expertise across Malta’s pharmaceutical sector:
Generic Pharmaceutical Manufacturers: Managing high-volume global aggregate reporting for portfolios leveraging Malta’s unique "Bolar Provision" and competitive patent environment.
EU/EEA Importers & Wholesalers: Supporting firms managing the transition of regulatory activities from the UK to Malta under the 2025 Windsor Agreement provisions.
Innovative Biotech Firms: Drafting complex PBRERs for new therapies emerging from Malta’s life sciences clusters and university-led research.
Local Contact Persons for Pharmacovigilance (LCPPV): Providing technical bandwidth to the mandatory local safety officers ensuring they are ready for MMA Good Pharmacovigilance Practice (GVP) inspections.
Art. 126(a) Authorization Holders: Ensuring that "duplicate" or nationally authorized products remain compliant with the latest safety reporting cycles.
Our PSUR & PBRER Services
Our scientific precision matches Malta’s commitment to pharmaceutical excellence and public health safety:
2025 IRIS-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully synchronized with the new EMA IRIS digital submission workflows effective February 2025.
Windsor Framework Compliance Support: Assisting MAHs in updating safety documentation and packaging narratives as regulatory activities move from the UK to the EU/Malta.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond simple data collation to provide a comprehensive clinical defense for the PRAC and MMA.
National PSUR Assessments: Managing submissions for purely nationally authorized products (NAPs) not included in the EURD list, ensuring compliance with MMA-specific submission fees and validation requirements.
Signal Detection & Literature Monitoring: Utilizing scientific methodologies to validate safety signals from global databases and local medical literature, specifically for the Maltese population.
Why Pharma Leaders in Malta Choose PSUR Central
"Scientific rigor for a strategic Mediterranean pharmaceutical gateway."
2025 Regulatory Specialists: Fully prepared for the IRIS platform transition and the Windsor Framework changes, ensuring your 2025 submission cycles are managed without technical or legal friction.
MMA GVP Inspection Ready: Our reports are designed to withstand the scrutiny of Malta Medicines Authority inspectors, with a 100% acceptance track record.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Seamless Local Support: We understand the nuances of the Maltese market, including the need for coordination with local QP (Qualified Person) certification and batch release activities.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Malta Medicines Act (2003): Including Article 31A standards on pharmacovigilance.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
Regulation (EU) 2023/1182 (Windsor Framework): Regarding medicinal products for human use.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Malta-based operations, we typically require:
Product Portfolio and target markets (Malta, EU, North Africa, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and Malta-specific).
Summary of ICSRs: Line listings and tabulations from the MMA database or your global safety database.
Submission Calendar: Coordination with EURD list deadlines or specific national renewal cycles (3-year or 5-year cycles).
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.