PSUR Central – Global PSUR Preparation & Review Services
Advancing Noida’s Global Pharma Corridor: US FDA | EU | WHO | PIC/S | CDSCO Compliance
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 and life sciences leaders of Noida and Greater Noida.
Noida has emerged as a critical node in India’s pharmaceutical export strategy, hosting state-of-the-art SEZ units and global research hubs. Since 2008, we have partnered with Noida’s industry leaders to deliver scientifically rigorous safety documentation that supports high-stakes exports to the US, Europe, and Japan, ensuring that your regulatory filings are as innovative as your manufacturing processes.
Who We Support in Noida & Greater Noida
We provide specialized pharmacovigilance expertise to the high-tech industrial clusters of the NCR:
SEZ-Based Exporters (Noida Phase II / Greater Noida): Managing global safety reporting for plants dedicated to the US (ANDA), EU, and UK markets.
Corporate R&D & Biotech Centers: Supporting clinical and post-marketing safety data synthesis for innovative pipelines and biosimilars.
Large-Scale Formulation Units: Providing aggregate reporting for diverse portfolios including tablets, capsules, and complex injectables.
Regulatory Affairs & PV Teams: Resolving CDSCO observations or responding to US FDA Form 483s related to periodic safety data evaluation.
Medical Device & Health-Tech Innovators: Drafting specialized safety summaries (SSCP/PSUR) for medical devices registered globally.
Our PSUR Services
We offer scientific excellence that matches the modern infrastructure of Noida’s pharma industry:
PBRER & PSUR Preparation: High-level technical writing following ICH E2C (R2) standards, emphasizing medical review and benefit-risk evaluation.
Technical Gap Analysis: Auditing existing safety databases and previous reports to ensure they meet the latest GVP (Good Pharmacovigilance Practices) standards.
Signal Detection & Management: Proactive scientific assessment of adverse event trends to identify potential safety signals from global data.
Authority Query Resolution: Specialized support in drafting technical responses to "Information Requests" from health authorities post-submission.
Integrated Safety Summaries: Combining domestic PvPI data with global safety insights for a unified regulatory narrative.
Global Experience & Regulatory Excellence
750+ PSURs prepared and successfully accepted by stringent global regulators.
Active since 2008: A long-standing partner to the NCR’s pharmaceutical export sector.
Deep Regulatory Exposure: Expert-level knowledge of US FDA, EMA, Health Canada, and MHRA expectations.
Broad Therapeutic Coverage: Extensive experience in CNS, Oncology, Endocrinology, and Chronic Care medications.
Why Noida’s Pharma Industry Chooses PSUR Central
"Scientific precision for the high-tech manufacturing hubs of North India."
Export-Ready Documentation: We specialize in the sophisticated technical writing required to clear the world’s most stringent regulatory hurdles.
Science-Driven Analysis: Every report undergoes rigorous medical review to ensure a defensible safety profile, moving beyond simple administrative data.
Seamless Scalability: We provide the technical bandwidth to handle large global portfolios during peak submission cycles or product renewals.
Confidentiality & Precision: Professional execution with a strict adherence to global submission timelines and data security.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard for periodic reporting).
US FDA Post-Marketing Safety Reporting (21 CFR 314.80).
EU GVP Module VII (Periodic Safety Update Reports).
CDSCO & PvPI (Pharmacovigilance Programme of India) mandates.
MDR/IVDR requirements for Medical Device safety reporting.
Get Started: Partner With Us
To provide a customized technical scope for your Noida-based facility or corporate office, we typically require:
Product Portfolio and target global markets.
Approved Labeling (SmPC / USPI / Product Monograph).
Global Sales & Exposure Data (Estimated patient-years/units).
Summary of ICSRs (Integrated Safety Database extracts).
Target Submission Deadlines.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.