PSUR Central – Global PSUR Preparation & Review Services
Advancing Nashik’s Pharma & Biotech Hub: 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 industrial powerhouses of Nashik, including the Satpur, Ambad, Sinnar, and Dindori MIDC zones.
As a critical center for global drug formulations and a growing destination for medical device innovation, Nashik-based companies face increasingly complex safety mandates. Since 2008, we have partnered with Nashik’s leading exporters and local manufacturers to deliver "authority-ready" safety documentation that ensures uninterrupted global approvals and successful regulatory inspections.
Who We Support in Nashik
We provide specialized pharmacovigilance expertise to Nashik’s dynamic industrial ecosystem:
Global Formulation Leaders (Satpur & Ambad): Managing safety reporting for high-volume exports of tablets, capsules, and injectables to the US (ANDA), EU, and UK.
MNC Manufacturing Units: Supporting the Nashik plants of global giants (like GSK and Glenmark) with overflow aggregate reporting and medical writing needs.
Sinnar & Dindori Industrial Clusters: Helping rapidly growing firms and specialized biotech units transition to high-growth international export compliance.
Medical Device & IVD Manufacturers: Providing specialized safety summaries for medical devices, in accordance with growing international and CDSCO requirements.
Regulatory & Quality Teams: Addressing technical queries from health authorities or preparing for WHO-GMP and PIC/S audits.
Our PSUR Services
We offer scientific excellence that matches the manufacturing precision of Nashik’s pharma industry:
PBRER & PSUR Preparation: Expert drafting in the ICH E2C (R2) format, focusing on cumulative benefit-risk evaluation for both legacy and new drugs.
Medical Device Safety Reporting: Specialized assessment for diagnostic and medical device portfolios registered in global markets.
Technical Gap Analysis: Auditing existing PSURs against international GVP (Good Pharmacovigilance Practices) to ensure readiness for US FDA and EMA inspections.
Signal Detection & Management: Utilizing scientific methodologies to validate and assess potential safety signals from global data sources.
Authority Query Resolution: Expert drafting of technical responses to "Information Requests" (IRs) or clarification requests from global regulators post-submission.
Global Experience & Trusted Expertise
750+ PSURs prepared and successfully accepted by the world's most stringent regulators.
Active since 2008: Long-standing partner to Maharashtra’s pharmaceutical export sector.
Multi-Region Coverage: Extensive experience across North America, Europe, Asia-Pacific, and the Middle East.
Therapeutic Depth: Specialized knowledge in Respiratory, Dermatology, Oncology, and Gastroenterology.
Why Nashik’s Pharma Leaders Choose PSUR Central
"Scientific rigor that bridges Nashik’s manufacturing excellence with global regulatory success."
Export-Ready Quality: We specialize in the high-level technical writing required to clear the world’s most stringent regulatory hurdles.
Science-Driven Evaluation: Our reports move beyond data entry, providing deep-dive clinical and safety assessments of your product's profile.
Reduced Regulatory Friction: High-quality reports lead to fewer authority observations and faster market entry for your global portfolio.
Confidentiality & Precision: Professional, deadline-driven execution that respects your manufacturing timelines and submission windows.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global standard for periodic safety 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.
ISO 13485 & related safety standards for Medical Devices.
Get Started: Partner With Us
To initiate a customized project for your Nashik-based facility, we typically require:
Product/Device 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.