PSUR Central – Global PSUR Preparation & Review Services
Supporting Bangalore’s Biotech & Pharma Innovation: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides dedicated Periodic Safety Update Report (PSUR) and PBRER services tailored for the cutting-edge pharmaceutical and biotech ecosystem of Bangalore.
As a global leader in Biosimilars, Biologics, and complex generics, Bangalore-based companies require safety reporting that matches their level of innovation. Since 2008, we have partnered with Bangalore’s industry leaders to deliver scientifically rigorous documentation that ensures uninterrupted global market access and successful health authority audits.
Who We Support in Bangalore
We provide specialized pharmacovigilance expertise to Bangalore’s diverse life sciences sector:
Biotech & Biosimilar Innovators: Managing complex safety profiles and global risk management plans (RMPs).
Large-Scale Generic Exporters: Supporting exports from Bangalore’s specialized SEZs to the US, EU, UK, and Japan.
R&D Focused Firms: Ensuring that clinical safety data transitions seamlessly into post-marketing periodic reports.
Regulatory Affairs & PV Teams: Addressing CDSCO observations or international "Warning Letters" related to safety data evaluation.
Clinical Research Organizations (CROs): Partnering to provide end-to-end safety reporting for their global clients.
Our PSUR Services
We offer scientific expertise that aligns with Bangalore’s high-tech pharmaceutical environment:
PSUR/PBRER Preparation: Drafting high-level technical reports following ICH E2C (R2) standards for NDAs, ANDAs, and BLAs.
Biologic-Specific Safety Reporting: Specialized assessment of immunogenicity and long-term safety data for Biosimilars and Biologics.
Technical Gap Assessment: Auditing existing PSURs against the latest global GVP (Good Pharmacovigilance Practices) to ensure audit readiness.
Authority Query Resolution: Expert handling of technical queries from the US FDA, EMA, or PMDA (Japan) post-submission.
Signal Detection & Medical Review: Proactive scientific evaluation of adverse event trends to ensure a favorable benefit-risk profile.
Global Experience & Regulatory Excellence
750+ PSURs prepared and successfully accepted by global regulators.
Active since 2008: Long-standing trust with India’s leading biotech and pharma firms.
Global Footprint: Extensive experience across North America, Europe, Asia-Pacific, and LATAM.
Complex Portfolio Coverage: Expertise in Monoclonal Antibodies, Vaccines, Injectables, and Orphan Drugs.
Why Bangalore’s Life Science Industry Chooses PSUR Central
"Scientific rigor for the innovation capital of India."
Innovation Focused: We understand the unique safety reporting requirements of complex biologics and new chemical entities (NCEs).
Science-Driven Analysis: Our reports go beyond administrative filing; we provide robust medical and scientific evaluations.
Global Audit Quality: We design reports to withstand inspections from the most stringent health authorities, including the US FDA and EMA.
Confidentiality & Precision: We operate with a professional, deadline-driven execution model that respects your intellectual property and submission windows.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard).
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.
WHO and PIC/S aligned country regulations.
Get Started: Partner With Us
To initiate a customized project for your Bangalore-based operations, we typically require:
Product/Biologic Portfolio and target global markets.
Approved Labeling (SmPC / USPI / Product Monograph).
Sales & Patient Exposure Data for the reporting period.
Adverse Event Summaries (ICSRs/Line Listings).
Submission Timelines.
Contact PSUR Central today to ensure your innovation meets the highest global safety standards.
Global PSUR Compliance. Science-Driven. Authority-Ready.