PSUR Central – Global PSUR Preparation & Review Services
Empowering Roorkee’s Pharma Cluster: 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 pharmaceutical manufacturing hub of Roorkee and the Bhagwanpur industrial area.
As a significant contributor to North India's pharmaceutical output, Roorkee-based companies are increasingly eyeing regulated markets. Since 2008, we have partnered with local manufacturers to ensure their safety documentation matches their production excellence, facilitating smoother exports and robust regulatory standings.
Who We Support in Roorkee
We provide specialized pharmacovigilance expertise to the industrial heart of Uttarakhand:
Formulation Manufacturers (Bhagwanpur & Roorkee): Managing safety reporting for solid orals, liquid orals, and topicals registered in ASEAN, CIS, and African markets.
Emerging Generic Exporters: Guiding firms through the complex safety mandates of the US FDA and EU as they scale their global footprint.
Quality & Regulatory Affairs Teams: Addressing CDSCO audit observations or deficiencies related to post-marketing safety data monitoring.
MSME Pharma Units: Providing cost-effective, high-level technical expertise to help smaller units achieve WHO-GMP and international PV compliance.
Our PSUR Services
We offer scientific precision that complements Roorkee’s engineering and manufacturing heritage:
PBRER & PSUR Preparation: Expert drafting in the ICH E2C (R2) format, ensuring a comprehensive evaluation of the benefit-risk profile for your products.
CDSCO & PvPI Compliance: Managing mandatory periodic safety reporting via the SUGAM portal for the Indian market.
Technical Gap Analysis: Auditing existing safety data to ensure it meets international GVP (Good Pharmacovigilance Practices) standards.
Signal Detection & Medical Review: Proactive evaluation of adverse events to identify trends and ensure ongoing patient safety.
Authority Query Management: Drafting technical responses to queries from health authorities post-submission to avoid product registration delays.
Global Experience & Trusted Expertise
750+ PSURs prepared and successfully accepted by international regulators.
Active since 2008: Long-standing partner to India’s pharmaceutical export sector.
Market Versatility: Proven success across Asia, Africa, Europe, and the Middle East.
Therapeutic Breadth: Expertise in Anti-infectives, Analgesics, Vitamins, and Chronic Care medications.
Why Roorkee Pharma Chooses PSUR Central
"Bridging the gap between Roorkee’s manufacturing strength and global regulatory expectations."
Quality-First Approach: We provide deep-dive clinical evaluations, not just simple data tabulations.
Audit-Ready Documentation: Our reports are designed to withstand scrutiny from the world’s most demanding health authorities.
Reliability & Confidentiality: Professional execution with a strict adherence to submission timelines and data privacy.
Cost-Effective Expertise: High-end scientific support scaled to meet the needs of Roorkee’s diverse manufacturing base.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The international standard for periodic reporting).
CDSCO & PvPI (Pharmacovigilance Programme of India) mandates.
US FDA Post-Marketing Safety Reporting (21 CFR 314.80).
EU GVP Module VII (Periodic Safety Update Reports).
WHO and PIC/S aligned country regulations.
Get Started: Partner With Us
To initiate a customized project for your Roorkee-based facility, we typically require:
Product Portfolio and target export markets.
Approved Labeling (Package Insert / SmPC / Product Monograph).
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.