🇦🇪 Regulatory Affairs Services in United Arab Emirates (UAE)

REGULATORY NEXUS GLOBAL

Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in the UAE

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 United Arab Emirates is one of the most advanced pharmaceutical and healthcare markets in the Middle East and a major gateway for healthcare product distribution across the Gulf Cooperation Council (GCC) region. Companies exporting pharmaceutical, nutraceutical, herbal and cosmetic products to the UAE must comply with national regulatory requirements, product registration procedures, and technical documentation standards.

REGULATORY NEXUS GLOBAL assists international manufacturers by preparing UAE-compliant regulatory dossiers, CTD documentation and scientific technical files required for successful product registration and market authorization.

Regulatory Authorities in the UAE

Medicinal products 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 healthcare authorities in major emirates:

• Dubai Health Authority (DHA)
• Department of Health – Abu Dhabi (DOH)

These authorities evaluate product quality, safety, efficacy, manufacturing standards and regulatory documentation before granting marketing authorization.

REGULATORY NEXUS GLOBAL supports companies in preparing regulatory dossiers aligned with UAE regulatory guidelines and GCC pharmaceutical regulatory standards.

Our Mission

Our mission is to simplify regulatory compliance for the UAE pharmaceutical and healthcare market and enable companies to successfully register and market pharmaceutical, nutraceutical, herbal and cosmetic products in the UAE through scientifically sound regulatory documentation.

Core Regulatory Services for UAE

CTD Dossier Preparation

Pharmaceutical product registration in the UAE typically follows the Common Technical Document (CTD) format aligned with ICH guidelines and GCC regulatory expectations.

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 requirements.

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 marketed in the UAE must comply with regulations of the Ministry of Health and Prevention and local municipal authorities.

Our services include:

• Nutraceutical regulatory documentation
• Ingredient compliance verification
• Product formulation documentation
• Export registration documentation

Herbal & Traditional Medicine Products

Herbal medicines and traditional health products must comply with regulatory safety and quality standards before marketing approval.

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 safety regulations and ingredient requirements.

Our services include:

• Cosmetic Product Information File (PIF)
• Cosmetic safety documentation
• Cosmetic regulatory compliance documentation
• Ingredient regulatory compliance
• Cosmetic product registration support

Veterinary Products

Veterinary medicinal products must comply with regulatory requirements before importation and distribution.

Our services include:

• 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 the UAE

GCC and Middle East Market Support

REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration across the GCC and Middle East region, including:

• UAE
• Saudi Arabia
• Qatar
• Oman
• Bahrain
• Kuwait
• Jordan
• Israel

Why Choose REGULATORY NEXUS GLOBAL

✔ Experienced regulatory affairs professionals
✔ Expertise in CTD dossier preparation
✔ Compliance with UAE and GCC 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 UAE and other regulated global markets.