PSUR Central – Republic of Congo

PSUR Preparation & Review Services

Ministry of Health – Republic of Congo | Directorate of Pharmacy & Medicines (DPM) | 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 Congo-based pharmaceutical companies, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Congolese 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 Ministry of Health of the Republic of Congo and the Directorate of Pharmacy & Medicines (DPM), uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in the Republic of Congo

PSUR Central works closely with:

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

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

Our PSUR Services – Republic of Congo

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per Ministry of Health / DPM Congo requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for DPM 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
• Republic of Congo MoH / DPM 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 DPM acceptance)

Why Companies in the Republic of Congo Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Central Africa, CEMAC & international markets
• Strong expertise in Francophone 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 Congo’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 (where applicable)
• 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 Republic of Congo MoH / DPM and global regulatory requirements.

PSUR Central

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

If you’d like, I can also:
✔ Add DPM Congo-specific PSUR FAQs
✔ Create a concise French–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for CEMAC / Central Africa registrations