🇦🇪 Regulatory Affairs Services in the United Arab Emirates
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in the United Arab Emirates
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 in the United Arab Emirates (UAE).
The UAE is one of the most important pharmaceutical and healthcare markets in the Middle East, with strict regulatory requirements for product registration, import approvals, and regulatory documentation.
REGULATORY NEXUS GLOBAL assists international manufacturers in preparing UAE-compliant regulatory dossiers, CTD documentation and scientific technical files required for successful product registration and market entry.
Regulatory Authority in the United Arab Emirates
Pharmaceutical and healthcare products in the UAE are regulated by the Ministry of Health and Prevention (MOHAP).
In addition, certain products may also be regulated through regional health authorities such as:
• Dubai Health Authority (DHA)
• Department of Health Abu Dhabi (DOH)
Product registration requires submission of technical dossiers, quality documentation, safety data and regulatory compliance documentation.
Our Mission
Our mission is to simplify regulatory compliance for the UAE pharmaceutical and healthcare market and enable companies to successfully register and commercialize pharmaceutical, nutraceutical, herbal and cosmetic products in the United Arab Emirates through scientifically sound regulatory documentation.
Core Regulatory Services for the UAE
CTD Dossier Preparation
Pharmaceutical product registration in the UAE generally follows the Common Technical Document (CTD) format aligned with ICH guidelines.
Our CTD dossier preparation services include:
• Module 1 – Administrative and regional information
• Module 2 – Quality Overall Summary (QOS) and expert reports
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports
• Module 5 – Clinical study reports / bioequivalence documentation
All documentation is prepared according to ICH guidelines and UAE regulatory expectations.
Regulatory Services for Multiple Product Categories
Pharmaceutical Products
• Generic drug registration dossiers
• CTD dossier preparation
• API documentation and Drug Master File (DMF) support
• Bioequivalence documentation
• CMC technical documentation
• Stability study documentation
Nutraceuticals & Food Supplements
Nutraceuticals and dietary supplements in the UAE must comply with regulatory requirements of the Ministry of Health and Prevention and local health authorities.
Our services include:
• Nutraceutical regulatory documentation
• Ingredient regulatory compliance verification
• Product formulation documentation
• Export registration documentation
Herbal & Traditional Medicine Products
Herbal products are regulated under UAE health authority guidelines.
Our services include:
• Herbal medicine regulatory dossiers
• Botanical ingredient documentation
• Traditional medicine regulatory documentation
• Export regulatory support
Cosmetics & Cosmeceuticals
Cosmetic products marketed in the UAE must comply with cosmetic regulations enforced by the Ministry of Health and Prevention and local authorities.
Our services include:
• Cosmetic Product Information File (PIF)
• Cosmetic safety documentation
• Cosmetic ingredient compliance documentation
• Cosmetic export registration support
Veterinary Products
• Veterinary medicinal product dossiers
• Veterinary regulatory documentation
• Export regulatory compliance support
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for UAE
Middle East Market Support
REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration across the Middle East including:
• United Arab Emirates
• Saudi Arabia
• Qatar
• Kuwait
• Oman
• Bahrain
• Jordan
• Israel
• Turkey
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in CTD dossier preparation
✔ Compliance with UAE regulatory frameworks
✔ Regulatory support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions for UAE market entry
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 the United Arab Emirates and other regulated global markets.