PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Latvian market, the messaging highlights Latvia’s specialized pharmaceutical landscape, characterized by its strong presence in the CIS and EU markets and its manufacturing hubs in Riga and Olaine. It focuses on compliance with the European Medicines Agency (EMA) and the State Agency of Medicines of the Republic of Latvia (ZVA).
PSUR Central – Global PSUR & PBRER Services
Strategic Compliance for Latvia’s Pharma Industry: EMA | ZVA | 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 Latvia’s historic pharmaceutical manufacturers and innovative life science firms.
Latvia is a vital player in the Baltic pharmaceutical sector, known for its expertise in organic synthesis and specialized generic manufacturing. As Latvian firms expand their reach into the broader European Union and regulated Western markets, the need for high-tier Pharmacovigilance (PV) documentation is critical. Since 2008, we have supported Latvian Marketing Authorization Holders (MAHs) in ensuring their safety dossiers meet the exacting standards of the EMA and the State Agency of Medicines (ZVA).
Who We Support in Latvia
We provide specialized pharmacovigilance expertise to the core of the Baltic pharmaceutical industry:
Latvian National Champions: Supporting established leaders in Riga and Olaine in managing global safety reporting for diverse portfolios exported to the EU and CIS regions.
Specialized Generic Manufacturers: Drafting PBRERs for complex delivery systems and specialized therapeutic areas like CNS and Cardiovascular health.
Export-Oriented SMEs: Assisting growing Latvian firms in scaling their regulatory documentation for Decentralized (DCP) and Mutual Recognition (MRP) procedures.
MNC Subsidiaries: Localizing global safety data to comply with Latvian national requirements and Baltic regional monitoring standards.
Regulatory & PV Managers: Addressing ZVA (Zāļu valsts aģentūra) inquiries and preparing for EMA-led GVP inspections.
Our PSUR & PBRER Services
We offer scientific excellence that matches Latvia’s heritage of pharmaceutical precision and chemical research:
EMA-Compliant PBRER Preparation: High-level drafting in the ICH E2C (R2) format, ensuring complete alignment with EU GVP Module VII.
Signal Detection & Analysis: Utilizing scientific methodologies to validate and assess safety signals using data from EudraVigilance and local Baltic sources.
Benefit-Risk Synthesis: Expert medical evaluation that provides a clear clinical justification for the continued authorization of your product.
EURD List & IRIS Management: Coordinating submission timelines with the EU Reference Date (EURD) list and managing digital submissions via the EMA 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 Latvia Choose PSUR Central
"Scientific rigor for the Baltic gateway to global pharmaceutical markets."
EU Regulatory Specialists: We specialize in the sophisticated technical writing required to clear the EMA’s stringent regulatory hurdles and PRAC assessments.
Science-Driven Quality: We go beyond mere data tabulation to provide deep-dive clinical evaluations that justify your product's market presence.
CIS & EU Market Knowledge: Unique expertise in harmonizing safety data for products that bridge the regulatory requirements of both the European Union and the CIS region.
Audit-Ready Documentation: Our reports have a 100% acceptance track record across all major EU National Competent Authorities.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
EU GVP Module VII: The mandatory European standard for Periodic Safety Update Reports.
ICH E2C (R2): The global gold standard for PBRER/PSUR.
ZVA Pharmacovigilance Guidelines: Local Latvian 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 Latvian-based operations, we typically require:
Product Portfolio and target markets (Latvia, EU, CIS, 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 EudraVigilance or your safety database.
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.