PSUR Central – Global PSUR & PBRER Services
Elite Compliance for Brazil’s Thriving Market: ANVISA | VigiMed | ICH | RDC 967/2025
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical, biological, and medical device sectors in Brazil—the largest healthcare market in Latin America.
Brazil is currently undergoing a major pharmacovigilance transformation. In March 2025, ANVISA published RDC No. 967/2025, introducing significant amendments to the foundational RDC No. 406/2020. This new regulation mandates the use of the VigiMed platform for all serious adverse event reporting and enforces the ICH E2B (R3) standard. With the 2025 phase-out of paper-based filings in favor of Datavisa/eCTD, our services ensure that your safety dossiers are technologically advanced and scientifically rigorous enough to meet the high standards of ANVISA’s clinical reviewers.
Who We Support in Brazil
We provide specialized pharmacovigilance expertise across Brazil’s complex regulatory landscape:
International Marketing Authorization Holders (MAHs): Managing global PBRER cycles for innovative medicines (Medicamentos Novos) and biologicals, ensuring 100% alignment with Portuguese labeling requirements.
Generic and "Similar" Drug Manufacturers: Navigating the unique Brazilian Medicamentos Similares category and the new "Clone" Registration process (RDC 954/2025) for faster market entry.
Local Representatives (Responsável Técnico): Providing the technical scientific back-end required by Brazil-based agents to manage VigiMed submissions and authority queries.
Medical Device & IVD Pioneers: Complying with the July 2025 UDI (Unique Device Identification) launch and the new safety performance frameworks under RDC 848/2024.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) under the newly streamlined 90-day review timelines for clinical research.
Our PSUR & PBRER Services
Our scientific precision aligns with ANVISA’s commitment to international convergence (ICH/PIC/S) and patient safety:
RDC 967/2025 Compliant Reporting: Expert drafting of safety reports utilizing mandatory MedDRA (for medical terms) and WHODrug Global (for medicines/vaccines) coding standards.
ICH E2B (R3) Data Integration: Preparing aggregate safety data in the XML-compatible formats required for the VigiMed system.
Portuguese Language Excellence: While global data is often in English, we provide high-level Portuguese technical summaries and safety narratives essential for ANVISA submissions.
Benefit-Risk Synthesis: Robust medical evaluations that justify the product’s safety profile within the specific context of the Brazilian Unified Health System (SUS).
eCTD Transition Support: Optimizing safety dossiers for Brazil’s fully paperless filing system, effective as of March 13, 2025.
Why Pharma Leaders in Brazil Choose PSUR Central
"Scientific rigor for one of the world's most complex and fast-moving regulatory environments."
2025 RDC Specialists: We are fully operational under the latest resolutions, including RDC 967/2025 (PV), RDC 964/2025 (Degradation Studies), and RDC 954/2025 (Registration).
Reliance Pathway Experts: We leverage ANVISA’s Optimized Reliance Procedure by aligning dossiers with FDA, EMA, and PMDA standards to accelerate your local approval times.
Pharmacovigilance System Master File (PSMF): We assist in maintaining a localized PSMF that is audit-ready for ANVISA’s increasingly frequent GMP and GVP inspections.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
RDC No. 406/2020 & RDC No. 967/2025: The governing resolutions for Good Pharmacovigilance Practices in Brazil.
Law No. 6.360/1976: The foundational legal pillar for drug regulation in the country.
ICH E2C (R2) & E2B (R3): The global benchmarks for periodic reporting and electronic data transmission.
MedDRA & WHODrug Global: Mandatory coding standards for the Brazilian National Health Surveillance System (SNVS).
Get Started: Partner With Us
To initiate a customized project for your operations in Brazil, we typically require:
Product Portfolio and registration type (New, Generic, Similar, or Biological).
VigiMed Access: Coordination information for your company's registered VigiMed user.
Approved Labeling: The Portuguese Bula (SmPC/PIL) as approved by ANVISA.
Local Safety Data: Summary of serious adverse events (SAEs) reported from the Brazilian market.
Submission Timeline: Coordination with your 10-year registration renewal cycles or specific ANVISA monitoring periods.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Brazil is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.