PSUR Central – Uganda
PSUR Preparation & Review Services
National Drug Authority (NDA) Uganda | US FDA | EU | WHO | PIC/S Aligned
PSUR Central is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for Uganda-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Ugandan market and regulated international destinations.
Since 2008, PSUR Central has supported pharmaceutical companies globally with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the National Drug Authority (NDA), Uganda, uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Uganda
PSUR Central works closely with:
• Ugandan pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with NDA Uganda
• Companies sourcing products from EU, India, ASEAN, MENA & other regulated markets
• Firms managing post-marketing safety obligations under NDA Uganda
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are designed to meet Uganda regulatory expectations while fully aligning with international pharmacovigilance requirements.
Our PSUR Services – Uganda
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per NDA Uganda and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for NDA authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and source markets
• Supply of authority-acceptable, ready-to-use PSUR templates
All PSURs are science-driven, non-generic, and authority-ready.
Regulatory Standards Followed
Our PSUR documentation is prepared in alignment with:
• ICH E2C (R2) Guidelines
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• NDA Uganda pharmacovigilance requirements
• Country-specific formats and reporting timelines
Product Types & Therapeutic Coverage
• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to NDA acceptance)
Why Companies in Uganda Choose PSUR Central
• Regulatory-focused, globally acceptable PSURs
• Templates accepted across East Africa, EAC & international markets
• Strong expertise in NDA Uganda and regional authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Uganda’s import-driven pharmaceutical system
How We Support You
To initiate PSUR preparation or review, we typically require:
• Product registration and approval details
• Approved labeling (SmPC / PI)
• Sales and patient exposure data
• Adverse event summaries
• Source countries and NDA submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with NDA Uganda and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and importers in Uganda with globally acceptable pharmacovigilance documentation.
If you’d like, I can also:
✔ Add NDA Uganda–specific PSUR FAQs
✔ Create a concise landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for EAC / East Africa regional registrations