PSUR Central – Global PSUR Preparation & Review Services
To adapt the PSUR Central webpage for the Guyana market, the messaging focuses on the requirements of the Government Technical Advisory Committee and the Food and Drug Department (GA-FDD) under the Ministry of Health. It also emphasizes Guyana’s growing alignment with CARICOM regional standards and the Caribbean Regulatory System (CRS).
PSUR Central – Global PSUR Preparation & Review Services
Empowering Guyana’s Pharma Sector: US FDA | EU | WHO | PIC/S | GA-FDD Compliance
PSUR Central, the specialized scientific division of Zoesoe Exports Pvt Ltd, provides comprehensive Periodic Safety Update Report (PSUR) preparation and review services for pharmaceutical companies, importers, and Marketing Authorization Holders (MAHs) in Guyana.
With the rapid expansion of the healthcare sector in Guyana, maintaining global safety standards is no longer optional. Since 2008, we have supported manufacturers and distributors with regulatory-compliant documentation that ensures seamless product registration, renewals, and safety monitoring.
Who We Support in Guyana
We provide expert pharmacovigilance services to:
Local Pharmaceutical Manufacturers aiming to export to the Caribbean (CARICOM), North America, and Europe.
Importers & Distributors in Guyana responsible for post-marketing safety reporting to the GA-FDD.
Regulatory Affairs Teams navigating the requirements of the Ministry of Health and the Caribbean Regulatory System (CRS).
Firms managing product renewals and variations for branded generics and essential medicines.
Our PSUR Services
We offer end-to-end support to ensure your safety documentation is scientifically sound and authority-ready:
PSUR/PBRER Preparation: Development of reports in strict accordance with ICH E2C (R2) standards and local Guyanese requirements.
Technical Review Services: Independent auditing of your existing safety reports to identify gaps before they reach the regulator.
Health Authority Query Handling: Specialized support in drafting responses to technical questions from the GA-FDD, US FDA, or EMA.
Benefit-Risk Evaluation: In-depth scientific assessment of your product’s safety profile based on global and local data.
Customized Templates: Providing ready-to-use, regulator-accepted templates for routine safety submissions.
Global Experience & Trusted Expertise
750+ PSURs prepared and successfully accepted by global health authorities.
Global Presence: Active since 2008 with a proven track record across the Caribbean, Latin America, Europe, and Asia.
Regulatory Exposure: Strong experience with the US FDA, WHO, PIC/S, and various Commonwealth Ministries of Health.
Wide Product Range: Expertise in Prescription Drugs, OTCs, Vaccines, and Fixed-Dose Combinations (FDCs).
Regulatory Standards Followed
Our documentation is prepared in total alignment with:
ICH E2C (R2) Guidelines (The international gold standard).
EU GVP Module VII (Periodic Safety Update Reports).
WHO Guidelines for Pharmacovigilance in developing markets.
US FDA Post-Marketing Safety Reporting requirements.
Guyana GA-FDD specific safety reporting mandates.
Why Guyanese Companies Choose PSUR Central
"Bridging the gap between local distribution and international safety excellence."
Export-Centric Approach: We help Guyanese firms meet the stringent requirements of highly regulated markets like the US and UK.
Science-Driven Analysis: Our reports go beyond data entry; we provide robust medical and scientific signal assessments.
Reduced Regulatory Friction: High-quality reports lead to fewer queries from the GA-FDD and faster renewal processes.
Confidentiality & Reliability: Professional handling of sensitive safety data with guaranteed adherence to submission deadlines.
How to Get Started
To provide a tailored technical scope and proposal for your portfolio, we typically require:
Product Registration Status in Guyana and export markets.
Approved Product Labeling (Package Inserts / SmPC).
Sales & Patient Exposure Data (Units sold / Patient-days).
Adverse Event Summaries (if any).
Target Submission Dates.
Contact PSUR Central today to ensure your products meet the highest global safety standards.
Global PSUR Compliance. Science-Driven. Authority-Ready.