PSUR Central – Global PSUR Preparation & Review Services
Empowering the Delhi NCR Pharma 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 for the pharmaceutical leaders of the National Capital Region.
Delhi NCR is not only the regulatory heart of India but also a global center for pharmaceutical corporate strategy and high-volume exports. Since 2008, we have partnered with NCR-based manufacturers and Marketing Authorization Holders (MAHs) to deliver "authority-ready" safety documentation that ensures global market dominance and successful health authority audits.
Who We Support in Delhi NCR
We provide specialized pharmacovigilance expertise to the core of the North Indian pharma cluster:
Corporate Regulatory Teams (Delhi/Gurgaon): Managing global safety portfolios for diverse international markets.
Export Units in Noida & Faridabad: Scaling manufacturing for the US, EU, UK, GCC, and ASEAN regions.
Generic & Branded Generic Leaders: Navigating the complex safety mandates required for ANDAs and global dossiers.
Regulatory & Quality Heads: Addressing CDSCO observations or responding to US FDA technical queries and deficiencies.
Startup & Mid-sized Pharma: Transitioning from domestic operations to high-growth international export compliance.
Our PSUR Services
We offer scientific excellence that matches the strategic and manufacturing standards of Delhi NCR’s industry:
PSUR/PBRER Preparation: Drafting comprehensive technical reports following ICH E2C (R2) standards for global renewals and routine submissions.
Technical Gap Assessment: Auditing existing PSURs against international GVP (Good Pharmacovigilance Practices) to ensure audit readiness for FDA and EMA inspections.
Authority Query Resolution: Expert drafting of technical responses to queries from health authorities post-submission.
Signal Detection & Risk Management: Proactive scientific evaluation of adverse event trends to ensure a favorable benefit-risk profile.
Legacy Data Conversion: Transitioning old formats into modern, ICH-aligned PBRERs.
Global Experience & Regulatory Reach
750+ PSURs prepared and successfully accepted worldwide.
Active since 2008: Long-standing partner to North India’s leading pharmaceutical exporters.
Global Footprint: Extensive experience across North America, Europe, Africa, Asia-Pacific, and the Middle East.
Therapeutic Depth: Expertise in Chronic Care, Antibiotics, Oncology, and Fixed-Dose Combinations (FDCs).
Why Delhi NCR Pharma Chooses PSUR Central
"Turning regulatory challenges into market advantages in the heart of India."
Export-Centric Quality: We specialize in the high-level technical writing required to clear the world’s most stringent regulatory hurdles.
Science-Driven Evaluation: Our medical and scientific experts provide a deep-dive evaluation of every safety signal, moving beyond simple data processing.
Reduced Regulatory Friction: High-quality reports lead to fewer authority observations and faster market entry.
Confidentiality & Precision: Professional, deadline-driven execution that respects your corporate strategy and submission windows.
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 Delhi NCR-based operations, 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.