PSUR Central – Global PSUR Preparation & Review Services
Advancing Faridabad’s Pharma Industry: 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 Faridabad.
As Faridabad evolves from an industrial giant into a sophisticated pharmaceutical export center, the need for high-quality technical documentation is critical. Since 2008, we have supported local manufacturers in navigating the transition from domestic compliance to meeting the stringent safety reporting standards of global health authorities.
Who We Support in Faridabad
We provide specialized pharmacovigilance expertise to the manufacturing core of Haryana:
Export-Oriented Units (EOUs): Managing safety reporting for products registered in the US, Europe, ASEAN, and the Middle East.
Mid-Sized Formulation Manufacturers: Bridging the gap between local production and global regulatory expectations.
Marketing Authorization Holders (MAHs): Ensuring periodic safety obligations are met for diverse product portfolios.
Regulatory & Quality Teams: Addressing CDSCO audit findings or preparing for international inspections (WHO-GMP, PIC/S).
Loan License & Contract Manufacturers: Providing high-quality safety reports for their domestic and international clients.
Our PSUR Services
We offer scientific excellence that complements Faridabad’s manufacturing precision:
PSUR/PBRER Preparation: Expert drafting of technical reports following ICH E2C (R2) standards for routine submissions and product renewals.
Technical Gap Analysis: Auditing existing safety data and previous reports to ensure they meet modern global standards.
Authority Response Support: Specialized assistance in drafting technical answers to queries from the CDSCO, FDA, or EMA post-submission.
Signal Detection & Medical Review: Proactive assessment of adverse event trends to ensure the ongoing safety and efficacy of your products.
Safety Data Integration: Harmonizing global safety data with local requirements for seamless multi-country submissions.
Global Experience & Trusted Expertise
750+ PSURs prepared and successfully accepted by international regulators.
Since 2008: Proven track record in supporting the Indian pharma industry's global growth.
Multi-Market Proficiency: Extensive experience across Asia, Africa, Europe, and the Americas.
Diverse Product Experience: Expertise in Generics, Fixed-Dose Combinations (FDCs), OTCs, and Chronic Care medications.
Why Faridabad Pharma Chooses PSUR Central
"Scaling manufacturing strength into global regulatory compliance."
Practical Solutions for MSMEs: We offer high-level expertise that is accessible to mid-sized manufacturers looking to enter regulated markets.
Scientific Depth: We move beyond data entry, providing clinical evaluations that demonstrate a product's true benefit-risk profile.
Audit-Ready Documentation: Our reports are built to withstand scrutiny from the world’s most demanding health authorities.
Reliability & Confidentiality: Professional execution with a strict adherence to international 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 Faridabad-based facility, we typically require:
Product List and target export markets.
Approved Labeling (SmPC / Product Monograph / PI).
Sales & Patient Exposure Data for the reporting period.
Adverse Event Summaries (ICSRs/Line Listings).
Submission Timelines.
Contact PSUR Central today to ensure your global exports remain compliant and authority-ready.
Global PSUR Compliance. Science-Driven. Authority-Ready.