PSUR Central – Global PSUR Preparation & Review Services
Empowering Surat’s Pharma Growth: 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 expanding pharmaceutical hub of Surat and South Gujarat.
As Surat diversifies its industrial base, local pharmaceutical manufacturers are increasingly competing on the global stage. Since 2008, we have partnered with emerging and established firms in Surat to ensure their safety documentation meets the stringent requirements of the US FDA, EMA, and CDSCO, facilitating seamless global market entry and sustained growth.
Who We Support in Surat
We provide specialized pharmacovigilance expertise to the industrial clusters of South Gujarat:
Export-Oriented Units (EOUs) in SEZs: Managing safety reporting for products registered in the United States, Europe, and ASEAN markets.
SME Formulation Units: Helping mid-sized manufacturers in Ichchhapore and Hazira navigate the transition to international safety standards.
Bulk Drug & Intermediate Manufacturers: Providing safety summaries and data support for global supply chain compliance and DMF filings.
Regulatory & Quality Teams: Addressing CDSCO observations or preparing for WHO-GMP and international health authority audits.
Ayurvedic & Herbal Exporters: Managing specialized safety documentation for Surat’s growing herbal medicine export sector.
Our PSUR Services
We offer scientific excellence that matches the modern infrastructure of Surat’s newer industrial parks:
PBRER & PSUR Preparation: Professional drafting in the ICH E2C (R2) format, ensuring a robust benefit-risk evaluation for global renewals.
Technical Gap Analysis: Auditing existing safety data and previous reports to ensure they meet the latest international GVP (Good Pharmacovigilance Practices) standards.
Authority Query Resolution: Expert assistance in drafting technical responses to "Information Requests" (IRs) from health authorities post-submission.
Signal Detection & Management: Proactive evaluation of adverse event trends to identify potential safety signals from your global or domestic data.
Local CDSCO Compliance: Managing mandatory periodic safety reporting via the SUGAM portal for the Indian market.
Global Experience & Trusted Expertise
750+ PSURs prepared and successfully accepted by international regulators.
Active since 2008: Long-standing partner to the Indian pharmaceutical export sector.
Market Versatility: Proven success across Asia, Africa, Europe, and the Middle East.
Product Depth: Expertise in Generic Formulations, FDCs, Biotics, and Specialized API safety data.
Why Surat’s Pharma Industry Partners with PSUR Central
"Scaling Surat’s manufacturing spirit into global regulatory confidence."
Quality-First Documentation: We provide high-level technical writing that moves beyond simple data entry to true clinical evaluation.
Audit-Ready Results: Our reports are built to withstand scrutiny from the world’s most demanding health authorities.
Reliability & Confidentiality: Professional execution with strict adherence to global submission timelines and data privacy.
Adaptive Solutions: We scale our services to meet the needs of both large-scale exporters and growing SMEs.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The international 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.
WHO and PIC/S aligned country regulations.
Get Started: Partner With Us
To initiate a customized project for your Surat-based facility, we typically require:
Product Portfolio and target global markets.
Approved Labeling (Package Insert / SmPC / USPI).
Sales & Patient Exposure Data for the reporting period.
Summary of ICSRs (Line Listings and tabulations).
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.