Navigate Africa’s Complex Regulatory
Environment with Confidence
Africa’s pharmaceutical market is experiencing rapid growth, driven by increasing healthcare needs, government initiatives, and demand for quality medicines. However, regulatory frameworks across the continent vary significantly, requiring a region-specific approach for successful market entry.
🌍 Countries We Serve Across Africa
NAFDAC (Nigeria) — FDA Ghana
PPB (Kenya) — NDA (Uganda)
EFDA — ZAMRA — TMDA
Morocco, Tunisia, Algeria — DPM Authorities
Comprehensive Pharmaceutical Regulatory Services Across Africa
At RABT Global, we deliver comprehensive Regulatory Services for Pharmaceuticals across African countries. Our team of regulatory experts helps you streamline approvals, stay compliant, and bring your products to market efficiently.
🇰🇪 Kenya
🇺🇬 Uganda
🇪🇹 Ethiopia
🇿🇲 Zambia
🇬🇭 Ghana
🇹🇿 Tanzania
🇲🇦 North Africa
🤝 Let’s Connect: Looking to register and commercialize your pharmaceutical products across Africa? Partner with RABT Global for complete regulatory support — from strategy to post-approval success.
Your Trusted Pharmaceutical Regulatory Partner in Africa
Experienced Team with cross-border project execution capabilities
Strong Local Partnerships with agents and in-country consultants
Compliance-Focused Approach aligned with global standards and local mandates
Our Key Services
No matter the country or complexity, our team helps you streamline approvals, stay compliant, and bring your products to market efficiently.
Regulatory Strategy & Market Access Planning
Product classification and eligibility assessment. Development of market access strategy and compliance roadmap.
Strategy
Dossier Preparation & Registration Support
Submission to national authorities — NAFDAC (Nigeria), PPB (Kenya), NDA (Uganda), ZAMRA (Zambia), EFDA (Ethiopia), DPM (Morocco, Tunisia). Life cycle management: renewals, variations, and updates.
Registration
GMP Certification & Site Registration
Preparation for GMP inspections and audits. Site registration with health authorities.
GMP
Local Agent & Pharmacovigilance Services
Local QPPV support for pharmacovigilance compliance. ICSR handling, PSUR submissions, and safety data monitoring.
Pharmacovigilance
Import Permits & Distribution Compliance
Labeling and packaging compliance as per national language and content rules. Liaison with customs and logistics teams.
Import & Distribution
Post-Market Regulatory Support
Product recalls and regulatory communication support. Monitoring regulatory changes and ensuring ongoing compliance.
Post-Market
Countries We Serve Across Africa
RABT Global supports pharmaceutical regulatory submissions and post-approval services across key African markets.
East & West Africa
Nigeria, Kenya, Uganda, Ethiopia, Zambia, Ghana, Tanzania
Nigeria — NAFDAC
Kenya — PPB
Uganda — NDA
Ethiopia — EFDA
Zambia — ZAMRA
Ghana — FDA Ghana
Tanzania — TMDA
North Africa
Morocco, Tunisia, Algeria
Morocco — North African DPM Authorities
Tunisia — North African DPM Authorities
Algeria — North African DPM Authorities