PSUR Central – Global PSUR & PBRER Services
To address the "Congo" market effectively, it is essential to distinguish between the two neighboring nations: the Democratic Republic of the Congo (DRC) and the Republic of the Congo. Both are currently undergoing major regulatory overhauls in 2025 to align with WHO Maturity Level standards and regional harmonization.
PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for the Congo Basin: ACOREP (DRC) | DPM (Congo) | ICH | WHO
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical and medical product sectors across both the Democratic Republic of the Congo (Kinshasa) and the Republic of the Congo (Brazzaville).
1. Democratic Republic of the Congo (DRC)
Focus: ACOREP | National Pharmacovigilance System
The DRC is the largest pharmaceutical market in Central Africa. As of 2025, the Congolese Pharmaceutical Regulatory Agency (ACOREP) has fully assumed all regulatory functions from the former DPM. Under Order 1250/SP013, the DRC’s National System of Pharmacovigilance now mandates that all Marketing Authorization Holders (MAHs) identify and report adverse effects, particularly those that are serious or unexpected.
ACOREP Compliance: We provide the technical dossiers required for ACOREP’s rigorous "Market Authorization" and "Renewal" processes.
Safety Monitoring: We assist in preparing reports for the National Pharmacovigilance Commission, which now oversees safety during both clinical trials and post-market use.
Multi-Regional Clinical Trials (MRCT): Specialized preparation of DSURs for sponsors conducting research in collaboration with the INRB (National Institute for Biomedical Research).
2. Republic of the Congo (Congo-Brazzaville)
Focus: DPM | Lomé Initiative | CEMAC Harmonization
In Brazzaville, the Directorate of Pharmacy and Medicine (DPM) is the primary authority. In 2025, the Congo is aggressively implementing the Lomé Initiative and the CEMAC Sub-Regional Plan to combat substandard and falsified medicines.
CTD Format & French Language: We ensure all PSURs and PBRERs are drafted in the mandatory CTD format and provided in high-level French, as required by DPM-Congo.
WHO Global Benchmarking Tool (GBT): Our reports are designed to help local and international firms align with the DPM’s ongoing "Maturity Level" strengthening, supported by the WHO.
5-Year Renewal Cycles: Managing the safety documentation necessary for the 5-year Marketing Authorization (MA) maintenance.
Our Specialized Services
Our scientific precision supports the public health goals of both Kinshasa and Brazzaville:
ICH E2C (R2) Compliant PBRER Preparation: Transitioning from simple data listings to robust Benefit-Risk Evaluations that satisfy Central African reviewers.
Post-Market Surveillance (PMS): Drafting the annual safety reports required for products registered through the CEMAC or national routes.
Bilingual Technical Writing: Full dossier preparation and translation in French and English, ensuring technical accuracy in both official regulatory languages.
Signal Detection: Utilizing scientific methodologies to validate and assess safety signals, incorporating data from the VigiBase system and local spontaneous reporting.
Why Pharma Leaders in the Congo Choose PSUR Central
"Scientific rigor for the most complex and growing markets in Central Africa."
2025 Regulatory Intelligence: We are fully operational under the new ACOREP mandates (DRC) and the Lomé Initiative (Republic of Congo).
Audit-Ready Quality: Our reports have a 100% acceptance track record across global regulatory agencies (EMA, US FDA, and African NRAs).
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Get Started: Partner With Us
To initiate a project for your operations in the DRC or the Republic of Congo, we typically require:
Product Portfolio and registration status (National or Regional).
Target Authority: Identification of ACOREP (Kinshasa) or DPM (Brazzaville) requirements.
Approved Labeling: The SmPC and Patient Leaflet in French.
Local Safety Data: Summary of ADRs reported from the local market.
Submission Timeline: Coordination with your 5-year renewal or specific authority requests.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in the Congo Basin is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.