PSUR Central – Côte d’Ivoire

• PSUR Preparation & Review Services

  Ministry of Health Côte d’Ivoire | 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 Côte d’Ivoire–based pharmaceutical companies, Marketing Authorization Holders (MAHs), and licensed importers supplying to the Ivorian 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, Côte d’Ivoire and the Directorate of Pharmacy and Medicine (DPM), uninterrupted product renewals, and effective post-marketing safety management.

  Who We Support in Côte d’Ivoire

  PSUR Central works closely with:

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

  Our services are designed to meet Côte d’Ivoire regulatory expectations while fully aligning with international pharmacovigilance requirements.

  Our PSUR Services – Côte d’Ivoire

  We provide complete lifecycle support for PSUR documentation, including:

  • PSUR preparation as per Ministry of Health / DPM Côte d’Ivoire 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
  • Côte d’Ivoire 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 Côte d’Ivoire Choose PSUR Central

  • Regulatory-focused, globally acceptable PSURs
  • Templates accepted across West Africa, ECOWAS & 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 Côte d’Ivoire’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 submission timelines

  Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Côte d’Ivoire MoH / DPM and global regulatory requirements.

  PSUR Central

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

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