PSUR Central – Global PSUR Preparation & Review Services
Supporting Suriname’s Healthcare Growth: US FDA | EU | WHO | PIC/S | MOH Suriname Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides comprehensive Periodic Safety Update Report (PSUR) preparation and review services for pharmaceutical companies and Marketing Authorization Holders (MAHs) in Suriname.
As Suriname continues to strengthen its regulatory framework, maintaining high-quality safety documentation is essential. Since 2008, we have supported manufacturers and importers with technical, authority-ready PSURs that ensure seamless product approvals, renewals, and compliance with the Inspectorate of Drugs (Inspectie der Geneesmiddelen).
Who We Support in Suriname
We provide specialized pharmacovigilance support to:
Pharmaceutical Importers & Distributors in Suriname responsible for managing the post-marketing safety of international brands.
Local Manufacturers aiming to export to the Caribbean (CARICOM), Latin America, or European markets.
Regulatory Affairs Professionals who need to address authority observations or safety data deficiencies.
Companies managing product renewals, ensuring all safety reporting is up-to-date and compliant with international ICH standards.
Our PSUR Services
We offer a full suite of services to ensure your safety reporting meets global benchmarks:
PSUR & PBRER Preparation: Development of reports aligned with ICH E2C (R2) guidelines and local Suriname requirements.
Scientific Gap Analysis: Independent review of existing safety data to identify any regulatory risks before submission.
Authority Response Support: Expert assistance in drafting technical responses to queries from the Ministry of Health or international regulators.
Risk-Benefit Assessments: In-depth evaluation of a product’s safety profile to support its continued presence on the market.
Global Templates: Providing standardized, regulator-accepted templates for routine safety monitoring.
Global Experience & Regulatory Reach
750+ PSURs prepared and successfully accepted worldwide.
Active since 2008 with deep experience in South America, the Caribbean, Europe, and Asia.
Strong Regulatory Exposure: Proven success with US FDA, EMA, WHO, and PIC/S aligned authorities.
Broad Coverage: Expertise in Generics, Fixed-Dose Combinations (FDCs), OTC medicines, and Traditional medicines.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard for safety reporting).
EU GVP Module VII (Periodic Safety Update Reports).
WHO Pharmacovigilance Guidelines for small and developing regulatory systems.
US FDA Post-Marketing Safety Reporting Requirements.
CARICOM/CRS regional safety standards.
Why Companies in Suriname Choose PSUR Central
"Reliable scientific expertise to bridge the gap between Suriname and global regulatory standards."
Regional Expertise: We understand the specific export/import challenges faced by firms in Suriname and the wider CARICOM region.
Non-Generic Approach: Our reports are science-driven and product-specific, providing more than just basic data entry.
Audit-Ready Quality: We deliver reports designed to withstand the most rigorous regulatory scrutiny.
Deadline Driven: Professional and confidential execution to ensure you never miss a submission window.
How to Get Started
To provide a customized technical scope and commercial proposal for your portfolio, we typically require:
Product Registration Details (Current status in Suriname and other markets).
Approved Labeling (Product Information / Inserts).
Sales & Patient Exposure Data (Units sold during the reporting period).
Adverse Event Summaries (ICSRs or safety signals).
Target Submission Timelines.
Contact PSUR Central today for expert guidance on your global safety compliance needs.
Global PSUR Compliance. Science-Driven. Authority-Ready.