PSUR Central – Global PSUR Preparation & Review Services
Partnering with Goa’s Global Exporters: 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 specifically designed for the high-volume manufacturing and export hubs of Goa.
From the Verna Industrial Estate to the clusters in Kundaim, Tuem, and Pilerne, Goa is a global powerhouse for finished dosages. Since 2008, we have supported Goa-based manufacturers in maintaining their edge in the most stringent global markets by delivering scientifically rigorous safety documentation that stands up to international scrutiny.
Who We Support in Panaji & Goa
We provide specialized pharmacovigilance expertise to the "Sunrise Industry" of the coastal state:
MNC & Large Domestic Manufacturers (Verna & Kundaim): Managing complex, multi-region safety reporting for global generic and innovative leaders.
Specialized Formulation Units: Drafting PBRERs for diverse dosage forms, including ophthalmic, injectables, and solid orals.
Export-Led Units (SEZs): Ensuring compliance for products exported to the United States, United Kingdom, and European Union.
Medical Device & IVD Innovators: Providing safety summaries (PSUR/SSCP) for Goa’s growing medical device bio-park sector.
Quality & Regulatory Heads: Responding to US FDA, UK MHRA, or CDSCO queries related to aggregate safety data and signal detection.
Our PSUR Services
We offer scientific excellence that matches the global regulatory certifications of Goan facilities:
PBRER & PSUR Preparation: Professional drafting in the ICH E2C (R2) format, ensuring a robust benefit-risk evaluation for global renewals.
Signal Detection & Analysis: Scientific evaluation of safety data to proactively manage the safety profile of your marketed products.
US FDA PADER Support: Specialized reporting for products approved under the ANDA/NDA pathways in the United States.
Technical Gap Analysis: Auditing existing pharmacovigilance systems and reports to ensure "audit-ready" status for international inspections.
Global Labeling Alignment: Harmonizing findings from safety reports with your USPI, SmPC, or CCDS.
Global Experience & Regulatory Reach
750+ PSURs prepared and accepted by global health authorities.
Since 2008: Proven track record in supporting the Goan pharma industry's global growth.
High-Stringency Expertise: Specialized knowledge in navigating US FDA, EMA, and UK MHRA expectations.
Therapeutic Breadth: Expertise in Cardiovascular, Anti-diabetic, Anti-infective, and Ophthalmic products.
Why Goa’s Pharma Industry Partners with PSUR Central
"Scientific precision for the export capital of Indian pharmaceuticals."
Export Specialist Mindset: We understand that for Goan firms, quality is not just a standard but a ticket to global markets.
Science-Driven Quality: We move beyond data entry, providing deep-dive clinical and medical assessments for every report.
Seamless Scalability: We provide the technical bandwidth to handle large global portfolios during peak submission cycles.
Confidentiality & Reliability: Professional execution with a strict adherence to international submission timelines and data privacy.
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 Goa-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 (Line Listings and tabulations).
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.