Regulatory Affairs Services in Africa
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in Africa
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services for pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies seeking product registration across African markets.
Africa represents one of the fastest-growing pharmaceutical and healthcare markets, with increasing regulatory oversight and product registration requirements. Each country has its own national regulatory authority, documentation requirements, and product approval procedures.
REGULATORY NEXUS GLOBAL supports companies by preparing country-specific regulatory dossiers, CTD documentation, and export registration files to enable successful product registration in African countries.
Regulatory Authorities in Africa
Pharmaceutical and healthcare products in Africa are regulated by national regulatory agencies such as:
• National Agency for Food and Drug Administration and Control (NAFDAC – Nigeria)
• South African Health Products Regulatory Authority (SAHPRA – South Africa)
• Pharmacy and Poisons Board (Kenya)
• Tanzania Medicines and Medical Devices Authority (TMDA – Tanzania)
• Food and Drugs Authority (Ghana)
• Egyptian Drug Authority (Egypt)
REGULATORY NEXUS GLOBAL prepares regulatory dossiers aligned with the requirements of African regulatory agencies and supports international companies exporting products to African markets.
Our Mission
Our mission is to simplify regulatory compliance for African markets and enable manufacturers to successfully register and commercialize pharmaceutical, nutraceutical, herbal and cosmetic products across Africa through scientifically sound regulatory documentation.
Core Regulatory Services for Africa
CTD Dossier Preparation
Many African regulatory authorities follow the Common Technical Document (CTD) format aligned with ICH guidelines.
Our CTD services include:
• Module 1 – Administrative and regional information
• Module 2 – Quality Overall Summary (QOS) and expert summaries
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports (where applicable)
• Module 5 – Clinical study reports / Bioequivalence reports
We ensure dossiers comply with WHO, ICH and African regulatory authority requirements.
Country-Specific Regulatory Dossiers for Africa
REGULATORY NEXUS GLOBAL prepares country-specific regulatory documentation for African markets including:
• East Africa
• West Africa
• North Africa
• Central Africa
• Southern Africa
Each dossier is customized according to country-specific regulatory submission requirements.
Regulatory Services for Multiple Product Categories
Pharmaceutical Products
• Generic drug registration dossiers
• CTD dossier preparation
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
Nutraceuticals & Food Supplements
• Export registration dossiers
• Ingredient regulatory compliance documentation
• Product formulation documentation
• Technical documentation for African regulatory authorities
Herbal & Traditional Medicine Products
• Herbal medicine regulatory dossiers
• Botanical ingredient documentation
• Traditional medicine registration documentation
• Export regulatory documentation
Cosmetics & Cosmeceuticals
• Cosmetic Product Information File (PIF)
• Cosmetic export registration dossiers
• Ingredient regulatory compliance documentation
• Cosmetic labeling compliance documentation
Veterinary Products
• Veterinary drug registration dossiers
• Veterinary product regulatory documentation
• Export registration documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence report documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for African markets
African Market Coverage
REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration in many African countries including:
• Nigeria
• South Africa
• Kenya
• Tanzania
• Uganda
• Ghana
• Ethiopia
• Egypt
• Morocco
• Algeria
• Zambia
• Zimbabwe
• Botswana
• Namibia
• Senegal
• Ivory Coast
• Rwanda
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in African regulatory frameworks
✔ ICH-compliant dossier preparation
✔ Support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Country-specific regulatory documentation
✔ End-to-end regulatory support for African markets
About Zoesoe Exports Pvt Ltd
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, a company engaged in global export consultancy, regulatory affairs services and contract manufacturing coordination for pharmaceutical, herbal, nutraceutical and cosmetic products.
Through its regulatory division, the company provides professional regulatory documentation and international product registration support for Africa and other global markets.