PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Portuguese market, the messaging highlights Portugal’s growing reputation as a European life sciences hub—driven by innovation in Lisbon and Porto—and focuses on compliance with INFARMED, I.P. and the mandatory 2025 transition to the SMUH-ALTER Portal and EMA IRIS platform.
PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Portugal’s Pharmaceutical Sector: INFARMED | EMA | ICH | US FDA
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the Portuguese pharmaceutical industry, ranging from global CDMO leaders to innovative biotech firms.
Portugal’s pharmaceutical market is on a steady growth trajectory, projected to reach USD 2.5 billion by the end of 2025. With major clusters in Lisbon (Oeiras) and the North (Porto/Maia), Portugal is a strategic entry point for clinical research and medicine supply chains in Europe. As of January 2025, the regulatory landscape is shifting toward full digital integration. Whether you are managing domestic registrations or global exports, our reports ensure you meet the rigorous expectations of INFARMED and the EMA.
Who We Support in Portugal
We provide specialized pharmacovigilance expertise across the Portuguese life sciences ecosystem:
International CDMOs & Generic Leaders: Supporting world-class manufacturing firms in Loures and Sintra with global aggregate safety reporting for exported portfolios.
Biotech & Oncology Innovators: Drafting complex PBRERs for advanced therapies and biologicals regulated under the Centralised Procedure.
National Marketing Authorization Holders (MAHs): Assisting Portuguese firms in complying with Decree-Law No 176/2006 and the latest safety monitoring mandates.
Local Pharmacovigilance Contact Persons: Providing technical bandwidth for the mandatory resident contact person in Portugal to manage signal detection and INFARMED communications.
Regulatory Teams Navigating 2025 Transitions: Managing the mandatory update of national contact details through the SMUH-ALTER Portal (required for all MAHs by January 31, 2026).
Our PSUR & PBRER Services
Our scientific precision matches the high standards of Portugal’s healthcare modernization strategy:
2025 Digital-Ready PBRER Preparation: Expert drafting in the ICH E2C (R2) format, fully integrated with the mandatory EMA IRIS platform as of January 2025.
SMUH-ALTER Portal Coordination: Assisting with the technical submission of safety contact updates and regulatory documentation via INFARMED's streamlined electronic gateway.
Benefit-Risk Synthesis: High-level medical evaluations that move beyond data collation to provide a robust clinical justification for the PRAC and INFARMED.
Signal Detection & Literature Monitoring: Scientific evaluation of safety signals using EudraVigilance and local Portuguese medical databases (e.g., InfoMed).
Technical Gap Analysis: Pre-audit reviews to ensure your safety dossiers are "authority-ready" for INFARMED GPvP inspections.
Why Pharma Leaders in Portugal Choose PSUR Central
"Scientific rigor for one of Europe's fastest-growing life science ecosystems."
2025 Compliance Experts: We are fully prepared for the SMUH-ALTER and IRIS platform requirements, ensuring your submission cycles remain uninterrupted.
Local Requirements, Global Standards: We understand the Portuguese mandate for a resident contact person and provide the back-end technical writing to support their legal responsibilities.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA, INFARMED, and the US FDA.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Decree-Law No 176/2006: The legal foundation for human medicines in Portugal.
INFARMED Circular No. 125/CD/2025: The updated procedure for national PV contact appointments.
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
Get Started: Partner With Us
To initiate a customized project for your Portuguese-based operations, we typically require:
Product Portfolio and target markets (Portugal, EU, Global).
Approved Labeling: The Portuguese SmPC (Resumo das Características do Medicamento) and Patient Leaflet (Folheto Informativo).
Estimated Patient Exposure: Units sold or patient-years (Global and Portugal-specific).
Summary of ICSRs: Line listings and tabulations from the INFARMED database or your global safety database.
Submission Calendar: Coordination with EURD list deadlines or specific national renewal cycles.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.