🇾🇪 Regulatory Affairs Services – Yemen
REGULATORY NEXUS GLOBAL
Yemen 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 Yemen.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Yemen regulatory framework and successfully registering their products for the Yemen market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Yemen regulatory authority requirements.
Yemen Regulatory Authority
Pharmaceutical products and healthcare products in Yemen are regulated by the Supreme Board of Drugs and Medical Appliances (SBDMA) under the Ministry of Public Health and Population Yemen.
The authority is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, biological products and medical devices
• Licensing of pharmaceutical importers and distributors
• Monitoring drug quality and safety
• Pharmacovigilance and post-marketing surveillance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with SBDMA regulatory requirements.
Our Mission
To simplify Yemen regulatory compliance and enable companies to successfully register and market their products in Yemen through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Yemen
Pharmaceutical Product Registration
We prepare Yemen-compliant pharmaceutical regulatory dossiers for submission to the Supreme Board of Drugs and Medical Appliances.
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 Yemen regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Pharmaceutical product registration in Yemen typically follows documentation structured according to the **Common Technical Document (CTD) format.
Our CTD dossier preparation services include:
• Module 1 – Administrative Information (Yemen-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 SBDMA regulatory expectations.
Pharmaceutical Registration Process in Yemen
The general process for pharmaceutical product registration in Yemen includes:
Appointment of a local Yemeni importer or authorized agent.
Submission of regulatory dossier and legal documentation to SBDMA.
Technical evaluation of product quality, safety and efficacy.
Regulatory review and compliance assessment.
Approval and issuance of marketing authorization for Yemen.
The registration process typically takes 8–12 months depending on the product category and regulatory review timeline.
Regulatory Services for Multiple Product Categories in Yemen
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Yemen has an emerging market for nutraceuticals and health supplements.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Products
Herbal medicines are commonly used in traditional healthcare systems in Yemen.
We provide regulatory documentation support including:
• Herbal product regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products must comply with national safety and regulatory documentation requirements before being marketed in Yemen.
Our services include:
• Cosmetic product technical documentation
• 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 Yemen
Yemen Market Entry Support
Our regulatory experts assist companies seeking to enter the Yemen pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• SBDMA regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in 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.