Connecting you with
Pharma regulatory compliance
We deliver end-to-end Regulatory Affairs and Pharmacovigilance solutions that transform complex data into authority-ready dossiers.
Our Competitive Edge
We ensure faster approvals, fewer queries, and sustained compliance across every African market we serve.
Regulatory Affairs &
Pharmacovigilance Services
Comprehensive regulatory solutions covering every phase of the pharmaceutical product lifecycle, delivered across all major African regulatory authorities.
african markets
service areas
E2E
full lifecycle
Regulatory Lifecycle Management (RLM)
A fully outsourced service that manages all regulatory affairs activities for a medicinal product from…
Market Intelligence & Regulatory Landscape Mapping (EAST AFRICA)
This service enables clients to navigate both formal regulations and the practical “unwritten rules” of…
Vendor Identification & Qualified Sourcing Support
We provide structured, compliance-focused sourcing support for pharmaceuticals, medical devices, and healthcare consumables, connecting clients…
Custom Regulatory Consulting
Not all regulatory challenges fit standard pathways. We provide tailored Regulatory Affairs consulting for complex,…
Lifecycle Management
Ensure sustained compliance and uninterrupted market presence through structured post-approval regulatory management for pharmaceuticals, medical…
Regulatory Strategy & Advisory
Regulatory success depends on informed planning, accurate interpretation of evolving requirements, and proactive risk management.…
Dossier Pre-Submission Review and Compliance
Regulatory authority queries often arise from dossier deficiencies. Our scientific team conducts in-depth dossier evaluations…
Product Registration Support
We support international Marketing Authorization Holders (MAHs) with end-to-end Regulatory Affairs (RA) services for the…
Pharmacovigilance (PV) Services
We provide end-to-end Pharmacovigilance system setup and operational support for pharmaceuticals, medical devices, and herbal…
Who We Serve
We support every stakeholder in the pharmaceutical supply and registration chain across African markets.
🏭 Pharmaceutical Manufacturers
📋 MAHs — Local & International
📦 Importers & Distributors
🌍 Exporters Entering Africa
🤝 Local Technical Representatives
🔬 Partner Consultancies
African Regulatory Authorities We Support
We support submissions to regulatory authorities across East, West, Southern, and Central Africa, including regional harmonization bodies. Physical dossier submission is currently available for East Africa.
- East Africa — NDA, PPB, TMDA, Rwanda FDA
- West Africa — NAFDAC, FDA Ghana, ECOWAS/WA-MRH
- Southern Africa — SAHPRA, ZAMRA, BoMRA, MCAZ, NMRC
- Central & Horn — EFDA, DPM-DRC, PMRA, Cameroon
- Regional Bodies — EAC-MRH, ECOWAS/WA-MRH
Loading map…
Accelerate Your Product’s
Regulatory Approval
Connect with our regulatory affairs team to discuss your market access needs, dossier requirements, or multi-country registration strategy.