PSUR Central – Global PSUR Preparation & Review Service
Fueling Vapi’s Global Pharma Exports: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific division of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services specifically for the industrial powerhouse of Vapi.
Vapi is a critical engine of the Indian pharmaceutical industry, characterized by its massive manufacturing capacity and rapid international expansion. Since 2008, we have partnered with Vapi-based manufacturers to bridge the gap between high-scale production and high-stringency regulatory compliance, ensuring your safety documentation is "authority-ready" for the world’s most demanding health agencies.
Who We Support in Vapi
We provide specialized pharmacovigilance expertise to the industrial heart of South Gujarat:
Mass-Scale Formulation Units (GIDC Vapi): Managing periodic safety reporting for oral solids, liquids, and topicals exported to the USA, UK, and EU.
API & Intermediate Leaders: Providing safety summaries and risk assessments for global DMF holders and bulk drug suppliers.
Export-Oriented SMEs: Assisting growing firms in navigating the complex safety mandates of the ASEAN, GCC, and CIS regions.
Contract Manufacturing Organizations (CMOs): Ensuring that safety data from diverse client portfolios is accurately synthesized for regulatory submissions.
Regulatory & Quality Teams: Addressing CDSCO audit queries or responding to US FDA technical deficiencies related to aggregate safety reporting.
Our PSUR Services
We offer scientific excellence that matches the industrial efficiency of Vapi’s pharma sector:
PBRER & PSUR Preparation: Professional drafting in the ICH E2C (R2) format, transforming raw safety data into a comprehensive benefit-risk narrative.
US FDA PADER Support: Specialized reporting for products approved under the ANDA pathway for the United States market.
Technical Gap Analysis: Auditing existing safety reports to ensure they meet modern GVP (Good Pharmacovigilance Practices) standards.
Signal Detection & Analysis: Scientific evaluation of adverse event trends to proactively manage the safety profile of your product portfolio.
Authority Query Resolution: Expert support in drafting technical responses to "Clarification Requests" from global health authorities post-submission.
Why Vapi’s Pharma Industry Partners with PSUR Central
"Translating Vapi’s manufacturing power into global regulatory success."
Direct Focus on Exports: We specialize in the sophisticated technical writing required to clear the world’s most stringent regulatory hurdles.
Science-Driven Quality: We move beyond administrative data entry, providing deep-dive clinical and medical assessments for every report.
Seamless Scalability: Our team can handle high-volume reporting cycles for companies with diverse and extensive product lists.
Local Context, Global Standards: We understand the operational realities of Vapi-based units while delivering quality that meets European and US expectations.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard).
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 Vapi-based facility, we typically require:
Product Portfolio and target global markets.
Approved Labeling (SmPC / USPI / Product Monograph).
Sales & Patient Exposure Data for the reporting period.
Summary of ICSRs (Integrated Safety Database extracts).
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.