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.

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, no matter the country or complexity.

Our Key Services

1. Regulatory Strategy & Market Access Planning

• In-depth regulatory intelligence for African nations (English, French, and Arabic-speaking regions)

• Product classification and eligibility assessment

• Development of market access strategy and compliance roadmap

2. Dossier Preparation & Registration Support

• Preparation and formatting of dossiers in CTD/eCTD formats

• Submission to national authorities such as:

  • SAHPRA (South Africa)

  • NAFDAC (Nigeria)

  • PPB (Kenya)

  • NDA (Uganda)

  • ZAMRA (Zambia)

  • EFDA (Ethiopia)

  • DPM (Morocco, Tunisia)

• Life cycle management: renewals, variations, and updates

3. GMP Certification & Site Registration

• Guidance for Good Manufacturing Practice (GMP) compliance

• Preparation for GMP inspections and audits

• Site registration with health authorities

4. Local Agent & Pharmacovigilance Services

• Appointing or coordinating with local representatives or distributors

• Local QPPV support for pharmacovigilance compliance

• ICSR handling, PSUR submissions, and safety data monitoring

5. Import Permits & Distribution Compliance

• Assistance with import license applications and supporting documentation

• Labeling and packaging compliance as per national language and content rules

• Liaison with customs and logistics teams

6. Post-Market Regulatory Support

• Adverse event reporting and risk mitigation

• Product recalls and regulatory communication support

• Monitoring regulatory changes and ensuring ongoing compliance

 Countries We Serve Across Africa

• South Africa (SAHPRA)

• Nigeria (NAFDAC)

• Kenya (PPB)

• Uganda (NDA)

• Ethiopia (EFDA)

• Zambia (ZAMRA)

• Ghana (FDA Ghana)

• Tanzania (TMDA)

• Morocco, Tunisia, Algeria (North African DPM Authorities)

Why RABT Global?

• Specialized Regulatory Knowledge of both Anglophone and Francophone 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

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.