PSUR Central – Global PSUR & PBRER Services
To adapt the PSUR Central webpage for the Canadian market, the content is tailored to the requirements of Health Canada and the Marketed Health Products Directorate (MHPD). The focus is on compliance with the Food and Drug Regulations and the adoption of the ICH E2C (R2) format for Annual Summary Reports (ASR) and PBRERs.
PSUR Central – Global PSUR & PBRER Services
Expert Health Canada Compliance: US FDA | EU | WHO | PIC/S | Health Canada
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides comprehensive Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) preparation and review services for the Canadian pharmaceutical and biotech industry.
Since 2008, we have supported Market Authorization Holders (MAHs) in Canada—from local manufacturers to global importers—in meeting the rigorous safety reporting standards required by Health Canada. We ensure your documentation supports product safety, efficacy, and continued market access.
Who We Support in Canada
We provide high-level pharmacovigilance expertise to:
Canadian MAHs (Brand & Generic): Managing domestic and international safety data for Health Canada submissions.
Biotech & Biologic Innovators: Requiring specialized PBRERs for complex therapeutic profiles.
Importers of Foreign Products: Ensuring global safety data is harmonized with Canadian Product Monographs (PM).
Regulatory Affairs Teams: Navigating Annual Summary Report (ASR) obligations and Health Canada-specific safety requests.
Specialized Services for the Canadian Market
Our services are meticulously aligned with the Food and Drug Regulations and Health Canada's guidance documents:
PBRER & PSUR Preparation: Drafting high-quality reports in the ICH E2C (R2) format, now the preferred standard in Canada.
Annual Summary Reports (ASR): Preparation of domestic safety summaries required under Section C.01.016 of the Regulations.
Safety Signal Assessment: Proactive identification and evaluation of potential safety concerns to protect Canadian patients.
Health Canada Query Management: Expert assistance in responding to Clarification Requests or Post-Market Surveillance inquiries.
Labeling Alignment: Ensuring the Adverse Reactions section of your Canadian Product Monograph remains current based on PSUR/PBRER findings.
Global Experience & Regulatory Excellence
750+ PSURs prepared and accepted globally.
Active since 2008: Long-standing expertise in Asia, Europe, and North America.
Regulatory Synergy: Proven success with Health Canada, US FDA, EMA, and MHRA.
Diverse Portfolio: Experience across Vaccines, Biologics, Prescription Drugs, and Natural Health Products (NHPs).
Regulatory Standards Followed
Our documentation is prepared in strict alignment with:
Health Canada Guidance: "Periodic Benefit-Risk Evaluation Report (PBRER) - International Council for Harmonisation (ICH) Topic E2C(R2)."
Food and Drug Regulations: Sections C.01.016 to C.01.020 (Post-market reporting).
ICH E2C (R2) Guidelines: The global gold standard for benefit-risk evaluation.
GVP (Good Pharmacovigilance Practices): Adhering to international quality systems for safety monitoring.
Why Canadian Companies Partner with PSUR Central
"Scientific rigor that meets Health Canada’s high standards for patient safety."
PBRER Format Mastery: We specialize in the modern PBRER format, which Health Canada prefers over the legacy PSUR.
Holistic Data Evaluation: We don't just report numbers; we provide a cumulative, integrated assessment of the product’s benefit-risk profile.
Audit-Ready Quality: Our reports are designed to withstand Health Canada inspections and "Clarification Requests."
Confidential & Deadline-Driven: We ensure your reports are submitted within the mandated windows (e.g., 70 or 90 days post-data lock).
How to Initiate Services
To provide a customized proposal for your Canadian portfolio, we generally require:
Drug Identification Number (DIN) and market authorization date.
Current Canadian Product Monograph (PM).
Canadian & Global Sales Data (patient exposure estimates).
Summary of Domestic & Foreign Adverse Reactions.
Data Lock Point (DLP) and submission deadlines.
Contact PSUR Central today for expert guidance on your Health Canada safety compliance.
Global Compliance. Science-Driven. Authority-Ready.