PSUR Central – Global PSUR Preparation & Review Services
To adapt the PSUR Central webpage for the Hyderabad market, the messaging highlights the city’s status as the "Pharma Capital of India" and a global leader in Vaccines, APIs, and Generic manufacturing. It focuses on supporting Hyderabad’s massive industrial base—from Genome Valley to the various Pharma SEZs—in meeting stringent international safety standards.
PSUR Central – Global PSUR Preparation & Review Services
Empowering the Hyderabad Pharma Powerhouse: 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 giants and innovative biotech firms of Hyderabad.
As the city responsible for a third of India's pharmaceutical exports, Hyderabad requires safety reporting that matches its massive manufacturing scale. Since 2008, we have partnered with Hyderabad-based global leaders to deliver scientifically rigorous documentation that ensures uninterrupted market access in the US, Europe, and beyond.
Who We Support in Hyderabad
We provide specialized pharmacovigilance expertise to the core of Hyderabad's pharma ecosystem:
Large-Scale Generic Manufacturers: Supporting massive export portfolios to the US (ANDAs) and EU from facilities in Jeedimetla, Pashamylaram, and beyond.
Vaccine & Biologics Innovators: Managing complex safety data for global vaccine distributions and biosimilar launches out of Genome Valley.
API & Bulk Drug Leaders: Providing safety summaries and supporting documentation for global DMF holders.
Corporate Regulatory Teams: Handling overflow and specialized medical writing for high-stakes PBRER submissions.
Contract Research & Manufacturing (CRAMS): Ensuring that safety reporting for international clients meets global GVP standards.
Our PSUR Services
We offer scientific excellence that aligns with Hyderabad’s reputation for pharmaceutical precision:
PBRER & PSUR Preparation: Expert drafting in the ICH E2C (R2) format, emphasizing cumulative benefit-risk evaluation for global submissions.
Vaccine Safety Reporting: Specialized assessments for multi-country vaccine programs, focusing on adverse events of special interest (AESI).
Technical Gap Analysis: Pre-audit reviews of safety reports to ensure they withstand US FDA, EMA, or WHO inspections.
Signal Detection & Evaluation: Utilizing advanced scientific methodologies to validate and assess potential safety signals from global datasets.
Authority Query Resolution: Expert handling of technical "Clarification Requests" or "Information Requests" from global health authorities post-submission.
Global Experience & Regulatory Excellence
750+ PSURs prepared and successfully accepted by the world's most stringent regulators.
Active since 2008: Long-standing trust with the largest pharmaceutical names in Hyderabad.
Deep FDA/EMA Exposure: Proven success in managing safety reporting for products under heavy regulatory scrutiny.
Diverse Therapeutic Depth: Expertise in Oncology, Vaccines, Anti-retrovirals, and Chronic Care.
Why Hyderabad’s Pharma Leaders Choose PSUR Central
"Scientific rigor for the pharmacy of the world."
Scale & Speed: We have the technical bandwidth to handle large-scale portfolios with multiple dosage forms and therapeutic areas.
Science-Driven, Not Template-Driven: Every report is a custom scientific evaluation, moving beyond administrative data entry to true medical analysis.
Audit-Ready Quality: Our reports are built to pass the highest level of scrutiny from the US FDA and European authorities.
Absolute Confidentiality: Professional execution with a focus on data security and strict adherence to global submission timelines.
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 requirements for Prequalified (PQ) medicines and vaccines.
Get Started: Partner With Us
To initiate a customized project for your Hyderabad-based operations, 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 (Line Listings and summary tabulations).
Data Lock Point (DLP) and 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.