🇳🇬 Regulatory Affairs Services – Nigeria
REGULATORY NEXUS GLOBAL
Nigeria Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services and product registration support for Nigeria.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Nigerian regulatory framework and successfully registering their products for the Nigerian market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Nigeria regulatory authority requirements.
Nigeria Regulatory Authority
Pharmaceutical products, medical devices, food supplements and cosmetics in Nigeria are regulated by the National Agency for Food and Drug Administration and Control (NAFDAC).
NAFDAC operates under the Federal Ministry of Health Nigeria and is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, vaccines and biological products
• Registration of food supplements and nutraceuticals
• Cosmetic product regulation
• Licensing of importers, manufacturers and distributors
• Quality control, inspection and compliance monitoring
• Pharmacovigilance and post-marketing surveillance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with NAFDAC regulatory requirements.
Our Mission
To simplify Nigeria regulatory compliance and enable companies to successfully register and market their products in Nigeria through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Nigeria
Pharmaceutical Product Registration
We prepare Nigeria-compliant pharmaceutical regulatory dossiers for submission to the National Agency for Food and Drug Administration and Control.
Our services include preparation of:
• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)
All dossiers are prepared according to NAFDAC regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Pharmaceutical product registration in Nigeria generally follows documentation structured according to the **Common Technical Document (CTD) format.
Our CTD dossier preparation services include:
• Module 1 – Administrative Information (Nigeria-specific requirements)
• Module 2 – Quality Overall Summary (QOS)
• Module 3 – Quality / CMC Documentation
• Module 4 – Non-Clinical Study Reports
• Module 5 – Clinical / Bioequivalence Study Reports
Our regulatory experts ensure dossiers comply with ICH guidelines, WHO standards and NAFDAC regulatory expectations.
Pharmaceutical Registration Process in Nigeria
The general process for pharmaceutical product registration in Nigeria includes:
Appointment of a local Nigerian marketing authorization holder or importer.
Submission of CTD regulatory dossier and legal documentation to NAFDAC.
Factory inspection or GMP verification by NAFDAC (for foreign manufacturers).
Product laboratory testing and technical evaluation.
Regulatory review and approval.
Issuance of NAFDAC Registration Number for market authorization.
The registration process typically takes 12–18 months depending on product category and regulatory review timeline.
Regulatory Services for Multiple Product Categories in Nigeria
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Food Supplements
Nigeria has one of the largest nutraceutical markets in Africa.
Our services include:
• Food supplement regulatory documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• NAFDAC product registration documentation
Herbal & Traditional Products
Herbal medicines are widely used in Nigeria and are regulated by NAFDAC.
We provide regulatory documentation support including:
• Herbal medicine regulatory dossiers
• Traditional medicine product documentation
• Safety and ingredient compliance documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products sold in Nigeria must be registered with NAFDAC.
Our services include:
• Cosmetic Product Information File (PIF) preparation
• Ingredient regulatory compliance verification
• Cosmetic product registration documentation
• Label compliance documentation
Veterinary Products
• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical scientific document writing
• Product development documentation
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Nigeria
Nigeria Market Entry Support
Our regulatory experts assist companies seeking to enter the Nigerian pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• NAFDAC regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in African regulatory requirements
✔ ICH-compliant regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.
If you want, I can also help you build a powerful SEO structure for Africa regulatory consulting such as:
Nigeria Pharmaceutical Registration
NAFDAC Drug Registration Services
Africa CTD Dossier Preparation
Pharmaceutical Export Registration Africa