🇸🇩 Regulatory Affairs Services – Sudan
REGULATORY NEXUS GLOBAL
Sudan 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 Sudan.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Sudanese regulatory framework and successfully registering their products for the Sudanese market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Sudan regulatory authority requirements.
Sudan Regulatory Authority
Pharmaceutical products, medical devices, food supplements and cosmetics in Sudan are regulated by the National Medicines and Poisons Board (NMPB).
The authority operates under the Federal Ministry of Health Sudan and is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, vaccines and biological products
• Registration of food supplements and nutraceuticals
• Regulation of cosmetics and medical devices
• Licensing of pharmaceutical manufacturers, importers and distributors
• Quality control and laboratory testing of medicines
• Pharmacovigilance and post-marketing surveillance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with NMPB regulatory requirements.
Our Mission
To simplify Sudan regulatory compliance and enable companies to successfully register and market their products in Sudan through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Sudan
Pharmaceutical Product Registration
We prepare Sudan-compliant pharmaceutical regulatory dossiers for submission to the National Medicines and Poisons Board.
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 Sudanese regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Pharmaceutical product registration in Sudan generally follows documentation structured according to the **Common Technical Document (CTD) format.
Our CTD dossier preparation services include:
• Module 1 – Administrative Information (Sudan-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 NMPB regulatory expectations.
Pharmaceutical Registration Process in Sudan
The general process for pharmaceutical product registration in Sudan includes:
Appointment of a local Sudanese marketing authorization holder or importer.
Submission of CTD regulatory dossier and legal documentation to the National Medicines and Poisons Board.
Technical evaluation of product quality, safety and efficacy.
Laboratory testing and regulatory review.
Approval and issuance of marketing authorization for Sudan.
The registration process typically takes 10–14 months depending on product category and regulatory review timeline.
Regulatory Services for Multiple Product Categories in Sudan
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Food Supplements
Sudan has a growing market for nutraceutical and dietary supplement products.
Our services include:
• Food supplement regulatory documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Products
Herbal medicines are widely used in Sudan and across the Middle East and North Africa region.
We provide regulatory documentation support including:
• Herbal medicine regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products marketed in Sudan must comply with national cosmetic safety and regulatory requirements.
Our services include:
• Cosmetic Product Information File (PIF) preparation
• Ingredient regulatory compliance verification
• Cosmetic product registration documentation
• Product safety 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 Sudan
Sudan Market Entry Support
Our regulatory experts assist companies seeking to enter the Sudanese pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• NMPB regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in African and Middle East 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.