PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Switzerland’s Life Sciences Hub: Swissmedic | TPA | ICH | US FDA
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium PBRER and PSUR services tailored for the Swiss Confederation’s elite pharmaceutical, biotech, and specialized medical clusters.
Switzerland is the "World’s Pharmacy," hosting the global headquarters of industry titans in Basel and innovative biotech hotspots in Zurich and the Vaud (Health Valley). With Swissmedic enforcing high-stringency safety standards under the Therapeutic Products Act (Status as of January 2025), and the updated guidance on PSUR/PBRER submission for Human Medicinal Products (HMP) effective March 2025, precision in safety reporting is non-negotiable. Since 2008, we have supported Swiss Marketing Authorization Holders (MAHs) in ensuring their safety dossiers meet both national mandates and global standards.
Who We Support in Switzerland
We provide specialized pharmacovigilance expertise across the Swiss life sciences landscape:
Global HQs & Multi-National Corporations (Basel): Managing high-volume, multi-regional PBRER cycles for innovative portfolios and established brands.
Biotech & Gene Therapy Innovators (Zurich/Vaud): Drafting complex safety reports for orphan drugs, advanced therapies, and breakthrough biologics.
Herbal & Complementary Medicine Producers: Ensuring compliance with the updated March 2025 Swissmedic guidance for Herbal Medicinal Products (HMP).
Local Responsible Persons for PV (QPPV): Providing technical bandwidth to the mandatory Swiss-resident QPPV for signal detection, medical writing, and ElViS (Electronic Vigilance System) submissions.
Clinical Trial Sponsors: Preparing Development Safety Update Reports (DSURs) for trials conducted in Switzerland's world-class university hospitals.
Our PSUR & PBRER Services
Our scientific precision matches the Swiss reputation for quality, neutrality, and excellence:
Swissmedic-Compliant PBRER Preparation: Expert drafting in the ICH E2C (R2) format, ensuring complete alignment with the Pharmacovigilance Ordinance (PVO) and TPA Art. 59.
Specialized Periodic Reporting for NAS: Managing the stricter 4-year periodic reporting cycle for products with a New Active Substance (NAS) (6-monthly for 2 years, then annually).
ElViS & Gateway Integration: Managing the technical submission of aggregate reports and supporting the electronic reporting of ICSRs via the Swissmedic Electronic Vigilance System.
Local Signal Detection & Assessment: Scientific evaluation of safety signals specifically for the Swiss patient population, incorporating local literature and spontaneous reports.
Benefit-Risk Synthesis: High-level clinical evaluations that provide a robust defense of your product's profile for Swissmedic technical committees.
Why Pharma Leaders in Switzerland Choose PSUR Central
"Scientific rigor for the world’s most sophisticated pharmaceutical regulatory environment."
2025 Guideline Specialists: Fully prepared for the March 2025 HMP guidance updates, ensuring your submissions reflect the latest editorial and content-related clarifications.
Swiss QPPV Support: We provide the "back-end" technical excellence required by your Swiss-resident QPPV to fulfill their legal duties under the TPA.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
100% Acceptance Rate: Our reports have a perfect track record with Swissmedic and other Level IV regulatory agencies (EMA, US FDA, PMDA).
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Therapeutic Products Act (TPA/HMG): Specifically Art. 59 regarding the duty to report.
Pharmacovigilance Ordinance (PVO/VAM): The primary regulation for safety monitoring in Switzerland.
ICH E2C (R2): The global benchmark for PBRER/PSUR.
Swissmedic Guidance MU103: Information on PSUR/PBRER submission for human medicinal products.
Get Started: Partner With Us
To initiate a customized project for your Swiss-based operations, we typically require:
Product Portfolio and target markets (Switzerland, EU, USA, Global).
Approved Labeling: The Swiss SmPC (Fachinformation) and Patient Information.
Estimated Patient Exposure: Units sold or patient-years (Global and Switzerland-specific).
Summary of ICSRs: Line listings and tabulations from the Swissmedic database and your global database.
Submission Calendar: Coordination with your "International Birthday" (IBD) or Swissmedic-specific cycles.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.