PSUR Central – Botswana

PSUR Preparation & Review Services

BOMRA | 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 Botswana-based pharmaceutical companies, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Botswana 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 Botswana Medicines Regulatory Authority (BOMRA), uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Botswana

PSUR Central works closely with:

• Pharmaceutical manufacturers and MAHs in Botswana
• Licensed importers, local agents, and distributors registered with BOMRA
• Companies sourcing products from EU, India, South Africa, ASEAN & other regulated markets
• Firms managing post-marketing safety obligations under BOMRA
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Botswana regulatory expectations while fully aligning with international pharmacovigilance requirements.

Our PSUR Services – Botswana

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per BOMRA 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 BOMRA 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
• BOMRA 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 BOMRA acceptance)

Why Companies in Botswana Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across SADC, Africa & international markets
• Strong expertise in African health authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Botswana’s import-driven pharmaceutical market

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 submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with BOMRA and global regulatory requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and importers in Botswana with globally acceptable pharmacovigilance documentation.

If you want next, I can:
✔ Add BOMRA-specific PSUR FAQs
✔ Create a concise landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for SADC or Southern Africa registrations