PSUR Central – Global PSUR & PBRER Services
Driving Indore’s Global Pharma Reach: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides comprehensive Periodic Safety Update Report (PSUR) and PBRER preparation and review services for the vibrant pharmaceutical industry in Indore and the Pithampur industrial belt.
With Indore’s SEZ recording a 32% jump in exports (primarily driven by US and European orders), maintaining world-class pharmacovigilance (PV) standards is no longer optional—it is a business imperative. Since 2008, we have helped Indore-based manufacturers transition from domestic players to global suppliers by ensuring their safety documentation meets the highest regulatory scrutiny.
Who We Support in Indore & Pithampur
We provide specialized pharmacovigilance expertise to Central India’s pharma heartland:
Pithampur SEZ Exporters: Managing safety reporting for high-volume exports to the United States, EU, and UK.
MNC Manufacturing Units: Supporting the local plants of global leaders (like Cipla, Lupin, and Glenmark) with overflow aggregate reporting needs.
API & Bulk Drug Manufacturers: Providing safety summaries for Drug Master Files (DMFs) and global supply chain compliance.
Formulation Specialists: Managing PBRERs for complex dosage forms, including injectables, ophthalmics, and oral solids.
MSMEs & Growing Brands: Helping mid-sized firms in Sanwer Road and Polo Ground industrial areas achieve WHO-GMP and international PV compliance.
Tailored Services for the Indore Market
Our services are designed to match the rapid industrial growth of the region:
PBRER & PSUR Preparation: Meticulous report writing following the ICH E2C (R2) standard, now a requirement for global registrations.
US FDA PADER Support: Specialized Periodic Adverse Drug Experience Reports (PADER) for products marketed in the United States.
CDSCO & PvPI Compliance: Ensuring all domestic safety obligations are met via the SUGAM portal and the Pharmacovigilance Programme of India.
Signal Detection & Analysis: Scientific evaluation of safety data to proactively manage the benefit-risk profile of your portfolio.
Authority Query Management: Expert assistance in responding to "Clarification Requests" from health authorities post-submission.
Global Experience & Regulatory Excellence
750+ PSURs prepared and accepted globally since 2008.
Deep Market Knowledge: Proven success with US FDA, EMA, Health Canada, and MHRA.
Therapeutic Expertise: Extensive experience in Cardiovascular, Anti-diabetic, Anti-infective, and Oncology segments.
Integrated Safety Approach: Combining clinical and post-marketing data for a robust benefit-risk evaluation.
Why Indore’s Pharma Leaders Partner with PSUR Central
"Turning Indore’s manufacturing prowess into global regulatory success."
Export Readiness: We specialize in the high-level technical writing required for the world's most stringent regulators.
Science-Driven Quality: We move beyond data entry, providing deep-dive medical and scientific assessments of your product's safety.
Scalable Bandwidth: Whether you have a single product or a portfolio of hundreds, we provide the bandwidth to meet tight regulatory windows.
Local Presence, Global Standards: We understand the unique challenges of the Indian manufacturing environment while delivering European/US quality.
Regulatory Standards We Follow
ICH E2C (R2): The global gold standard for PBRER/PSUR.
CDSCO Schedule Y: Guidelines for the Indian market.
EU GVP Module VII: European Union standards for periodic safety reporting.
US FDA 21 CFR 314.80: Post-marketing safety reporting requirements for the US.
Get Started: Elevate Your Compliance
To provide a customized proposal for your Indore-based facility, we generally require:
Product List and target export markets.
Current Approved Labeling (Package Insert / SmPC / USPI).
Sales Data (Patient exposure estimates) for the reporting period.
Adverse Event Summaries (Line Listings and summary tabulations).
Submission Deadlines.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global Compliance. Science-Driven. Authority-Ready.