PSUR Central – Global PSUR Preparation & Review Services
To adapt the PSUR Central webpage for the Kolkata (West Bengal) market, the messaging highlights the city's legacy as a pioneer in Indian pharmaceuticals and its strategic role as the gateway to South East Asia and neighboring SAARC nations. It focuses on supporting Kolkata’s established legacy brands and emerging biotech units in meeting international safety standards.
PSUR Central – Global PSUR Preparation & Review Services
Empowering Kolkata’s Pharma Heritage: 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 industry of Kolkata and the growing industrial clusters in West Bengal.
As Kolkata-based firms expand their global footprint into regulated markets like the US and Europe while maintaining strongholds in South East Asia, the complexity of safety reporting has intensified. Since 2008, we have partnered with Kolkata’s manufacturers to deliver scientifically rigorous documentation that bridges the gap between traditional excellence and modern global regulatory requirements.
Who We Support in Kolkata
We provide specialized pharmacovigilance expertise to the diverse life sciences sector of Eastern India:
Kolkata’s Legacy Pharma Brands: Modernizing periodic safety reporting for established portfolios entering regulated markets.
Export-Oriented Units (EOUs): Managing safety documentation for products registered in ASEAN, GCC, and CIS regions.
Biotech & Nutraceutical Firms: Providing specialized safety assessments for biologic products and high-end healthcare supplements.
Regulatory Affairs & PV Teams: Addressing CDSCO observations or preparing for international audits (WHO-GMP, PIC/S).
SAARC Market Specialists: Harmonizing safety data for companies focusing on Bangladesh, Nepal, and Sri Lanka alongside global markets.
Our PSUR Services
We offer scientific excellence that aligns with Kolkata’s academic and industrial precision:
PBRER & PSUR Preparation: Expert drafting in the ICH E2C (R2) format, providing a comprehensive assessment of the benefit-risk profile.
Technical Gap Analysis: Auditing existing reports to ensure they meet the stringent expectations of the US FDA, EMA, or UK MHRA.
Signal Detection & Medical Review: Proactive evaluation of safety data to identify new trends and ensure patient safety.
Post-Submission Support: Drafting technical responses to health authority queries or "Request for Further Information" (RFI).
Global Labeling Alignment: Ensuring that safety findings are accurately reflected in the Core Company Data Sheet (CCDS) and local Package Inserts.
Global Experience & Regulatory Excellence
750+ PSURs prepared and successfully accepted by international regulators.
Active since 2008: Long-standing partner to India’s leading pharmaceutical exporters.
Strategic Market Knowledge: Deep expertise in navigating the regulatory nuances of the EU, USA, and South East Asia.
Therapeutic Depth: Extensive experience in Gastrointestinal, Respiratory, Anti-infective, and Ayurvedic/Herbal safety reporting.
Why Kolkata’s Pharma Industry Chooses PSUR Central
"Scientific rigor that respects legacy while embracing global innovation."
Science-Driven Analysis: We move beyond data entry, providing clinical evaluations that demonstrate a product's true benefit-risk profile.
Customized Solutions: Whether you are a large corporation or a specialized niche manufacturer, our services are scaled to your needs.
Audit-Ready Documentation: 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.
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 Kolkata-based facility, we typically require:
Product Portfolio and target export markets.
Approved Labeling (SmPC / Product Monograph / PI).
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.