PSUR Central – Global PSUR Preparation & Review Services
Supporting Trinidad & Tobago Pharma: US FDA | EU | WHO | PIC/S | CARICOM Compliance
PSUR Central, the specialized scientific division of Zoesoe Exports Pvt Ltd, provides end-to-end Periodic Safety Update Report (PSUR) preparation and review services for pharmaceutical companies, distributors, and Marketing Authorization Holders (MAHs) in Trinidad and Tobago.
Since 2008, we have empowered local manufacturers and regional distributors with high-quality, authority-ready safety documentation, ensuring uninterrupted product registrations and full compliance with both local and global pharmacovigilance mandates.
Who We Support in Trinidad & Tobago
We cater to the unique needs of the T&T pharmaceutical sector, including:
Local Pharmaceutical Manufacturers expanding their export footprint to the US, UK, and EU.
Regional Distributors & MAHs responsible for post-marketing surveillance across the Caribbean.
Regulatory Affairs Teams preparing submissions for the Ministry of Health (CFDD) and the Caribbean Regulatory System (CRS).
Firms managing renewals for branded generics, FDCs, and OTC medicines.
Our PSUR Services
We provide a comprehensive suite of services to ensure your safety reporting is seamless and robust:
Global Standard Preparation: PSURs/PBRERs developed in strict accordance with international ICH and EU GVP standards.
CARICOM-Specific Alignment: Documentation tailored to meet the requirements of the Caribbean Regulatory System (CRS).
Authority Query Resolution: Expert assistance in handling technical queries from the US FDA, EMA, or local MOH.
Safety Data Gap Analysis: Evaluation of your current safety data to ensure it meets modern global pharmacovigilance expectations.
Template Supply: Provision of validated, ready-to-use templates for routine safety reporting.
Global Experience & Proven Success
750+ PSURs prepared and successfully submitted globally.
Global Outreach: Active since 2008 with deep experience in Asia, Africa, Europe, and Latin America.
Broad Portfolio: Expertise in Generics, Biologics, Fixed-Dose Combinations, and Legacy products.
Trusted by Authorities: Proven track record with the US FDA, EU Authorities, WHO, and PIC/S member countries.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard).
EU GVP Module VII (Periodic Safety Update Reports).
WHO Pharmacovigilance Guidelines for developing nations.
US FDA Post-Marketing Safety Reporting Requirements.
Local T&T Regulations and CARICOM regional standards.
Therapeutic Areas Covered
Prescription Pharmaceuticals
Over-the-Counter (OTC) Medicines
Fixed-Dose Combinations (FDCs)
Active Pharmaceutical Ingredients (APIs)
Herbal & Complementary Medicines
Why T&T Companies Partner with PSUR Central
"Bridging the gap between Caribbean distribution and global safety compliance."
Export-Ready Documentation: We specialize in getting products ready for highly regulated markets like the US and Europe.
Scientific Rigor: Our reports include thorough signal detection and risk-benefit assessments, moving beyond simple data entry.
Cost-Effective Outsourcing: Access world-class pharmacovigilance expertise without the overhead of an in-house global safety team.
Reliability: We operate with professional, deadline-driven execution to ensure your product remains on the market without interruption.
Contact Us to Get Started
To provide a customized proposal for your product portfolio, we generally require:
Product Registration History and target markets.
Current Approved Labeling (Package Inserts / SmPC).
Sales Data & Patient Exposure estimates.
Adverse Event Data (if any).
Submission Deadlines.
Contact PSUR Central today to ensure your portfolio meets global safety standards.
Global PSUR Compliance. Science-Driven. Authority-Ready.