PSUR Central – Global PSUR & PBRER Services
Expert FDA Compliance: US FDA | ICH | PADER | PBRER | REMS Support
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) preparation and review services for the U.S. pharmaceutical industry.
With over 15 years of experience, we support NDA, ANDA, and BLA holders in navigating the complex landscape of FDA post-marketing safety requirements. We ensure that your periodic reports are not just administrative filings, but robust, science-driven evaluations that withstand FDA scrutiny.
Who We Support in the United States
We provide strategic pharmacovigilance solutions to:
Generic Drug Manufacturers (ANDA Holders): Managing complex portfolios requiring streamlined yet compliant PBRER/PADER submissions.
Innovator & Biotech Firms (NDA/BLA Holders): Requiring in-depth signal detection and benefit-risk assessments.
Foreign Manufacturers & Exporters: Ensuring that safety data from global markets is correctly integrated for U.S. regulatory submissions.
Regulatory & Safety Teams: Facing FDA observations, Complete Response Letters (CRLs), or requiring overflow support for routine submissions.
Specialized U.S. Safety Services
Our services are designed to meet the specific demands of the Center for Drug Evaluation and Research (CDER) and CBER:
PBRER & PADER Preparation: Expert drafting of reports in accordance with 21 CFR 314.80 and ICH E2C (R2) guidelines.
PBRER Conversion: Seamlessly transitioning your reporting from the legacy PADER format to the comprehensive, ICH-aligned PBRER format.
Signal Detection & Evaluation: Utilizing advanced scientific methodologies to identify and evaluate potential safety signals.
FDA Query Management: Professional drafting of technical responses to FDA inquiries or information requests (IRs) post-submission.
Gap Analysis & Audit Readiness: Comprehensive review of existing safety databases and previous reports to ensure compliance with the latest FDA expectations.
Global Reach, Local Expertise
750+ Reports successfully submitted to global health authorities.
Since 2008: Proven track record in managing safety data for thousands of patients across diverse therapeutic areas.
Deep FDA Exposure: Extensive experience in handling post-marketing requirements for the U.S. FDA, EMA, Health Canada, and MHRA.
Technological Agility: Familiarity with various safety databases and E2B (R3) reporting standards.
Regulatory Standards & Compliance
Our documentation is strictly aligned with:
21 CFR 314.80 & 600.80: Post-marketing reporting of adverse drug experiences.
ICH E2C (R2): The global standard for Periodic Benefit-Risk Evaluation Reports (PBRER).
FDA Guidance for Industry: Including "Periodic Safety Reports—Using the ICH E2C(R2) Format."
E2B (R3): Standardized electronic transmission of Individual Case Safety Reports (ICSRs).
Why U.S. Companies Choose PSUR Central
"Scientific rigor that safeguards your market authorization and patient safety."
Science-Driven Evaluation: We prioritize medical review and clinical data synthesis over automated data entry.
Seamless Integration: Our reports aggregate global safety data (from clinical trials and post-marketing) to provide a unified benefit-risk profile.
Cost-Efficiency: Access high-level PV expertise without the overhead of an expanded in-house safety department.
Deadline Integrity: We understand the critical nature of the 60-day or 90-day FDA filing windows and guarantee on-time delivery.
Partner With Us
To initiate a project or request a proposal for your U.S. portfolio, we typically require:
Application Type: (NDA, ANDA, or BLA) and approval dates.
U.S. Prescribing Information (USPI): The current approved labeling.
Patient Exposure Data: Estimated number of patients exposed in the U.S. and globally.
Summary of ICSRs: Line listings and summary tabulations for the reporting interval.
Reporting Frequency: (Quarterly, Annual, or 3-year cycles).
Contact PSUR Central today to ensure your FDA periodic reporting is authority-ready and scientifically robust.
Global Compliance. Science-Driven. Authority-Ready.