PSUR Central – Global PSUR Preparation & Review Services
Empowering Visakhapatnam’s Export Giants: 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 powerhouses of Visakhapatnam.
With Vizag emerging as the "Pharma Gateway of the East Coast," the region's focus has shifted toward high-stringency markets in the US and Europe. Since 2008, we have partnered with Vizag-based global leaders to deliver "authority-ready" safety documentation that ensures uninterrupted market access and successful health authority audits.
Who We Support in Visakhapatnam
We provide specialized pharmacovigilance expertise to the core of Andhra Pradesh's pharmaceutical sector:
JNPC (Parawada) & Pharma SEZ Units: Managing safety reporting for high-volume exports of APIs and formulations to the USA (ANDA), EU, and UK.
Global Generic Leaders: Supporting the Vizag-based manufacturing sites of multinational firms with specialized aggregate reporting and medical writing.
Bulk Drug & Intermediate Manufacturers: Providing safety summaries and data support for global supply chain compliance and DMF maintenance.
Regulatory & Quality Teams: Addressing CDSCO observations or responding to US FDA Form 483s related to post-marketing safety data evaluation.
New-Age Biotech Units: Managing complex safety data for biosimilars and high-value biological products emerging from Vizag’s innovation parks.
Our PSUR Services
We offer scientific excellence that matches the world-class infrastructure of Vizag’s industrial zones:
PBRER & PSUR Preparation: High-level technical drafting in the ICH E2C (R2) format, focusing on medical review and cumulative benefit-risk synthesis.
Signal Detection & Management: Utilizing scientific methodologies to identify, validate, and evaluate potential safety signals from global adverse event data.
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they meet the latest global GVP (Good Pharmacovigilance Practices) standards.
US FDA PADER Support: Specialized periodic reporting for products approved under the US regulatory pathway.
Authority Query Resolution: Expert assistance in drafting technical responses to "Information Requests" from the FDA, EMA, or CDSCO post-submission.
Why Visakhapatnam’s Pharma Industry Chooses PSUR Central
"Scientific precision for India’s fastest-growing pharmaceutical coast."
Export-Ready Documentation: We specialize in the sophisticated technical writing required to clear the world’s most stringent regulatory hurdles.
Science-Led Evaluation: Every report undergoes rigorous medical review to ensure a defensible safety profile, moving beyond simple data entry.
Audit-Proven Quality: Our documentation has a 100% acceptance track record across all major Level IV regulatory agencies.
Reliability & Confidentiality: Professional execution with a strict adherence to global submission timelines and data security.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global 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 Visakhapatnam-based facility, we typically require:
Product Portfolio and target global markets.
Approved Labeling (SmPC / USPI / Product Monograph).
Global Sales & Exposure Data (Estimated patient-years/units sold).
Summary of ICSRs (Integrated Safety Database extracts).
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.