PSUR Central – Global PSUR Preparation & Review Services
Empowering Thane’s Pharma Industry: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific division of Zoesoe Exports Pvt Ltd, provides end-to-end Periodic Safety Update Report (PSUR) and PBRER services for the pharmaceutical and biotech powerhouses of Thane and the surrounding MMR industrial zones.
Thane has long been a cornerstone of India’s pharmaceutical success, hosting everything from legacy formulation plants to cutting-edge research centers. Since 2008, we have partnered with Thane-based manufacturers to ensure their safety documentation meets the evolving demands of the US FDA, EMA, and CDSCO, maintaining the region's reputation for regulatory excellence.
Who We Support in Thane
We provide specialized pharmacovigilance expertise to the core of Thane’s industrial landscape:
Thane-Belapur Road Manufacturers: Managing global safety reporting for large-scale exporters to the US, EU, and UK.
Wagle Estate Corporate & R&D Hubs: Supporting regulatory teams in synthesizing clinical and post-marketing safety data for new product launches.
Ambernath & Badlapur Chemical Clusters: Providing specialized safety assessments and summaries for API and bulk drug manufacturers.
Specialty Generic Exporters: Drafting PBRERs for complex delivery systems, including oncology, inhalers, and specialized injectables.
Quality & Regulatory Heads: Responding to health authority observations or preparing for WHO-GMP and PIC/S inspections.
Our PSUR Services
We offer scientific depth that matches Thane’s high industrial and clinical standards:
PBRER & PSUR Preparation: High-level technical drafting in the ICH E2C (R2) format, providing a robust medical evaluation of the benefit-risk profile.
Global Safety Signal Detection: Utilizing scientific methodologies to identify and validate safety signals from global adverse event data.
Technical Gap Analysis: Auditing existing safety reports to ensure they align with current GVP (Good Pharmacovigilance Practices) and international standards.
Authority Query Resolution: Expert support in drafting technical responses to "Information Requests" from global regulators post-submission.
Medical Review & Scientific Writing: Ensuring every report is scrutinized by medical experts to produce a scientifically defensible safety narrative.
Why Thane’s Pharma Industry Chooses PSUR Central
"Scientific rigor for one of India's most established pharmaceutical hubs."
HQ-Quality Documentation: We provide the level of technical writing required by corporate regulatory headquarters to clear stringent global hurdles.
Science-Driven Evaluation: We move beyond simple data collation, providing deep-dive clinical assessments that demonstrate product safety.
Audit-Ready Results: Our reports are built to withstand the highest level of scrutiny from the US FDA, EMA, and other Level IV regulators.
Confidentiality & Precision: Professional execution with 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 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 provide a customized technical scope for your Thane-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).
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.