PSUR Central – Global PSUR Preparation & Review Services
Empowering Chennai’s Pharma Ecosystem: 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 and life sciences industry in Chennai and the Tamil Nadu industrial belt.
With Chennai being home to some of India’s most technologically advanced manufacturing plants and clinical research facilities, the need for high-quality regulatory documentation is paramount. Since 2008, we have supported Chennai’s manufacturers and exporters in delivering "authority-ready" safety reports that ensure uninterrupted global approvals and successful regulatory inspections.
Who We Support in Chennai
We provide specialized pharmacovigilance expertise to Chennai’s diverse industrial landscape:
Chennai-based Formulation Manufacturers: Managing safety reporting for exports to the US, EU, UK, ASEAN, and GCC markets.
Large-scale Exporters in SEZs: Supporting firms operating out of the various Special Economic Zones (SEZs) in and around Chennai.
Global Capacity Centers (GCCs) & KPOs: Partnering with Chennai’s knowledge centers to manage global safety reporting overflows.
Regulatory & Quality Assurance Teams: Addressing CDSCO observations or responding to US FDA Form 483s related to post-marketing safety data.
Niche Biotech & API Units: Providing specialized safety assessments for complex therapeutic products and active ingredients.
Our PSUR Services
We offer scientific excellence that matches Chennai’s reputation for healthcare and engineering precision:
PSUR/PBRER Preparation: Drafting comprehensive technical reports in accordance with ICH E2C (R2) standards for NDAs, ANDAs, and BLAs.
Technical Gap Analysis: Auditing existing PSURs against international GVP (Good Pharmacovigilance Practices) to ensure audit readiness for US FDA and EMA inspections.
Authority Query Resolution: Specialized support in drafting responses to technical questions from the US FDA, EMA, or Country MOHs post-submission.
Signal Detection & Medical Assessment: Proactive evaluation of safety data to ensure a robust benefit-risk profile for your products.
Legacy Report Conversion: Transitioning legacy PADERs or old-format PSURs into modern, ICH-aligned PBRERs.
Global Experience & Regulatory Reach
750+ PSURs prepared and accepted by global health authorities.
Active since 2008: Long-standing partner to India’s leading pharmaceutical exporters.
Multi-Region Expertise: Extensive experience across North America, Europe, Asia-Pacific, Middle East, and Africa.
Therapeutic Depth: Expertise in Cardiovascular, Oncology, Anti-diabetic, and Anti-infective portfolios.
Why Chennai Pharma Chooses PSUR Central
"Scientific precision for the health capital of India."
Quality over Quantity: We don't just process data; our medical and scientific experts provide a deep-dive evaluation of every safety signal.
Export-Ready Quality: We specialize in the high-level technical writing required to clear the world’s most stringent regulatory hurdles.
Reduced Regulatory Risk: Our reports are designed to minimize follow-up queries, ensuring your product lifecycle remains on track.
Confidentiality & Reliability: We operate with a professional, deadline-driven model that respects the fast-paced manufacturing environment of Chennai.
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 Chennai-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.
Adverse Event Summaries (Line Listings/Tabulations).
Target Submission Deadlines.
Contact PSUR Central today to ensure your global safety compliance is authority-ready.
Global PSUR Compliance. Science-Driven. Authority-Ready.