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UAE Regulatory Affairs

Pharmaceutical and medical device registration in the UAE.

A specialist regulatory affairs consultancy delivering product registration, market authorisation, and ongoing compliance for foreign manufacturers entering the United Arab Emirates.

Register your product Explore services

Working directly with every UAE healthcare regulator.

UAE Ministry of Health & Prevention Emirates Drug Establishment Dubai Health Authority Dubai Municipality Department of Health, Abu Dhabi
02 · What we do

What we do.

01Pharmaceuticals
Pharmaceutical product registration

MOHAP and EDE dossier preparation, classification, and certificate issuance for foreign manufacturers entering the UAE market.

02Medical Devices
Medical device registration

Site registration, classification, and Authorised Representative services across every risk class, from Class I to implantable.

03Representation
Local Representative & MAH services

Hold your UAE market authorisation through our licensed local entity, without setting up your own. A practical local presence, as a service.

04Digital Health
Telehealth & telemedicine licensing

DHA telehealth licensing, provider onboarding, and NABIDH integration so you launch compliant remote care in the UAE.

05Clinic Set-up
DHA licensing & clinic set-up

Facility and professional licensing, NABIDH, and inspection readiness, from an empty unit to an open, licensed clinic in Dubai.

06Post-Market
Pharmacovigilance & post-market

QPPV, safety reporting, and post-market surveillance to keep your registered products compliant for the long term.

All services

Twenty years of end-to-end regulatory experience across every UAE healthcare authority.

One accountable engagement, from dossier to market authorisation.

Working directly with
UAE Ministry of Health & Prevention Emirates Drug Establishment Dubai Health Authority logo Dubai Municipality logo Department of Health, Abu Dhabi
04 · Industries

Industries.

Any company introducing a regulated healthcare product into the UAE.

01
Pharmaceuticals
02
Medical Devices
03
Digital Health & Telehealth
04
Cosmetics & Cosmeceuticals
05
Health Supplements & Nutraceuticals
06
Biotech & Biologics

Artwork and translation, built for UAE submissions.

Every dossier, leaflet, and label that goes to a UAE regulator has to be bilingual, formatted to spec, and ready for both submission and print. We run both workstreams in-house.

11Artwork Services

Compliant artwork, ready for submission and print.

UAE regulators require product artwork (packaging, labelling, leaflets, and inserts) to meet specific bilingual, regulatory, and formatting standards before approval. We design, adapt, and finalise compliant artwork for every product we register, ready for submission and ready for print.

What's included
  • Primary and secondary packaging artwork design
  • Carton, label, and blister foil artwork
  • Patient Information Leaflet (PIL) design and layout
  • Summary of Product Characteristics (SmPC) formatting
  • Instructions for Use (IFU) layout for medical devices
  • English and Arabic bilingual artwork
  • MOHAP and EDE artwork compliance review
  • Braille placement and verification where required
  • Barcode, batch number, and serialisation layout (Tatmeen-compliant)
  • Artwork variations for line extensions and pack sizes
  • Pre-print proofing and approval coordination
  • Artwork lifecycle management for renewals and variations
12Translation Services

Certified Arabic translation by regulatory linguists.

Every regulatory submission, label, leaflet, and supporting document destined for UAE authorities must be available in Arabic, accurate, certified, and aligned with regulatory terminology. We provide certified medical and pharmaceutical translation by translators with regulatory expertise, not generic linguists.

What's included
  • Arabic translation of product dossiers and registration files
  • Translation of Patient Information Leaflets (PILs)
  • Translation of Summary of Product Characteristics (SmPCs)
  • Translation of Instructions for Use (IFUs)
  • Translation of labels, packaging, and artwork
  • Translation of Certificates of Free Sale and supporting documents
  • Translation of clinical trial protocols and consent forms
  • Translation of pharmacovigilance reports and safety updates
  • Certified and legalised translation for regulatory submissions
  • Back-translation and translation verification
  • Terminology consistency across product portfolios
  • Multi-language support beyond Arabic where required

Dubai Municipality product registration services.

Every product category sits under a separate Dubai Municipality portal, with its own compliance standards, testing protocols, and labelling rules. We route each submission through the correct pathway on the first attempt.

Cosmetic Product Registration

Register all cosmetics, skincare, makeup, haircare, perfumes, and personal care products with Dubai Municipality. We manage formulation compliance, label review, Arabic translation, and full submission.

  • Skincare and anti-aging products
  • Makeup and color cosmetics
  • Hair care and styling products
  • Personal care items
  • Fragrances and perfumes
Learn more

Health Supplement Registration

Register vitamins, minerals, protein powders, herbal supplements, and sports nutrition products with Montaji portal. We handle ingredient safety assessment, claim compliance, and coordinate any required laboratory testing for full regulatory approval.

  • Vitamins & minerals
  • Herbal supplements
  • Protein powders & sports nutrition
  • Weight management products
  • Functional foods
Learn more

Food Product Registration

Register packaged and processed foods with Dubai Municipality. We handle nutritional analysis, shelf-life documentation, Arabic labeling, and halal certification coordination for full food safety compliance.

  • Packaged and processed foods
  • Beverages and drinks
  • Dietary supplements
  • Organic and natural products
  • Import and re-export facilitation
Learn more

Detergent & Cleaning Products

Register household cleaners, industrial detergents, disinfectants, and sanitizers with Dubai Municipality. We manage chemical safety assessments, MSDS documentation, biocidal product compliance, and eco-label requirements.

  • Household cleaners
  • Industrial detergents
  • Disinfectants and sanitizers
  • Personal hygiene products
  • Eco-friendly cleaning solutions
Learn more
05 · Why us

Why work with us.

01

Regulatory affairs is what we do.

We are not a generalist consultancy with a regulatory practice on the side. Product registration is our core discipline, and every other service we offer exists to support it.

02

Direct relationships with the regulators.

Our submissions go to MOHAP, EDE, DHA, and DOH technical committees we already know. That shortens timelines and clears blockers faster than firms working through intermediaries.

03

Licensed UAE entity, not a paperwork shop.

We hold our own drugstore licence, medical warehouse, and importer credentials. We can act as your Local Representative and Marketing Authorization Holder under UAE law, not just file submissions on your behalf.

04

End-to-end execution.

From the moment we receive your manufacturer dossier to the day the registration certificate is issued, we run every workstream , translation, attestation, classification, submission, follow-up, and certification.

Begin a registration

Bringing a pharmaceutical product or medical device to the UAE?

Send us the manufacturer details and the product specification. We'll come back with a registration roadmap, classification opinion, and indicative timeline within 48 hours.

Start your registration