PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Lithuania’s Life Science Hub: EMA | VVKT | 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 Lithuania’s world-class biotechnology and pharmaceutical sectors.
As Lithuania pursues its ambitious goal of becoming a global leader in life sciences by 2030, the demand for sophisticated regulatory documentation has never been higher. Since 2008, we have supported Lithuanian Marketing Authorization Holders (MAHs) in navigating the complex EU GVP landscape, ensuring that safety reports for innovative biologics and specialized generics satisfy the rigorous standards of the EMA and the State Medicines Control Agency (VVKT).
Who We Support in Lithuania
We provide specialized pharmacovigilance expertise to Lithuania’s high-tech pharmaceutical ecosystem:
Biotech & Biosimilar Innovators (Vilnius): Drafting complex PBRERs for recombinant proteins, enzymes, and advanced therapy medicinal products (ATMPs).
Specialized Generic Manufacturers (Kaunas): Managing periodic safety reporting for established portfolios in CNS, cardiovascular, and metabolic health.
High-Growth Life Science Startups: Supporting emerging firms in scaling their safety documentation for global market entry and Decentralized (DCP) procedures.
MNC Manufacturing & R&D Sites: Providing aggregate reporting support for international giants with substantial operations in Lithuania.
Regulatory & PV Managers: Addressing VVKT (Valstybinė vaistų kontrolės tarnyba) inquiries and preparing for EMA-led GVP inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Lithuania’s reputation for biotechnological precision and digital innovation:
EMA-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring 100% alignment with EU GVP Module VII.
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess potential safety signals from EudraVigilance and local Baltic databases.
Benefit-Risk Synthesis: High-level medical evaluation that moves beyond administrative data to provide a robust clinical defense of your product’s profile.
EURD List & IRIS Management: Coordinating submission timelines with the EU Reference Date (EURD) list and managing submissions via the EMA’s IRIS portal.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the expectations of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
Why Pharma Leaders in Lithuania Choose PSUR Central
"Scientific rigor for the Baltic region’s fastest-growing life sciences sector."
EU Regulatory Specialists: We focus on the high-level technical writing required to clear the world’s most demanding health authority reviews.
Biotech-Ready Expertise: Specialized knowledge in managing the unique safety reporting nuances required for biologics and high-tech medicinal products.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across the EMA and other Level IV regulatory agencies (US FDA, PMDA).
Reliability & Precision: Professional execution with strict adherence to European data privacy standards (GDPR) and submission timelines.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The mandatory standard for Periodic Safety Update Reports in the EU.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
VVKT Guidelines: Local Lithuanian requirements and national safety monitoring standards.
EMA/PRAC Requirements: Specific European expectations for signal management and benefit-risk evaluation.
Get Started: Partner With Us
To initiate a customized project for your Lithuanian-based operations, we typically require:
Product Portfolio and target markets (Lithuania, EU, USA, Global).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Reference Safety Information (RSI).
Estimated Patient Exposure: Units sold or patient-years (Global and EEA-specific).
Summary of ICSRs: Line listings and tabulations from your safety database or EudraVigilance.
Submission Calendar: Coordination with EURD list deadlines or global 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.