PharmaregUAE

Pharmaceutical and medical device registration services in the UAE

Anchored around regulatory affairs and product registration, with operational and strategic services built around them. Jump to any service below.

01Registration
Pharmaceutical Product Registration

End-to-end MOHAP and EDE registration of pharmaceutical products for foreign manufacturers.

02Registration
Medical Device Registration

Full registration of medical devices across every risk class, from Class I to implantable.

03Representation
Local Representation & MAH

We can act as your UAE Local Representative and Marketing Authorization Holder.

04Lifecycle
Regulatory Affairs Lifecycle

Variations, renewals, and changes managed for the life of your registration.

05Safety
Pharmacovigilance & Post-Market

QPPV, safety reporting, and post-market surveillance for foreign marketing authorisation holders.

06Quality
Quality & Compliance

Quality systems, audits, and compliance support for UAE healthcare products.

07Digital health
Telehealth & Telemedicine

DHA telehealth licensing, provider onboarding, and NABIDH integration.

08Logistics
Import Licensing & Warehousing

Import licences, medical warehousing, and compliant distribution across the UAE.

09DHA
DHA Licensing & Clinic Set-up

Facility and professional licensing for new clinics in Dubai.

10Advisory
Strategic Advisory

Regulatory strategy and market-access planning for entering the UAE.

11Market access
Market Access UAE

Pricing, importation, distribution, and launch: everything between certificate and first purchase order.

12Importation
Pharmaceutical Importation

Import into the UAE under our own licensed facility, medical warehouse, and importer credentials.

13Permits
EDE Import Permits

Emirates Drug Establishment import permits prepared, submitted, and issued under our licence.

14APIs
API Import & Registration

Active pharmaceutical ingredient source registration, permits, and GDP storage for manufacturers and traders.

15Peptides
Peptide Import & Registration

EDE classification, registration, and cold chain importation for peptide therapeutics.

16EDE guide
Emirates Drug Establishment

Every EDE service explained: classification, registration, permits, and facility licensing.

17Facilities
Pharmaceutical Warehouse Setup

Turnkey medical warehouse and scientific office licensing, or storage under our own licence.

18Commercial
Distributor Onboarding

Shortlisting, due diligence, negotiation, and onboarding of the right UAE distributor.

19Licensing
Facility Licensing & Renewals

New licences, renewals, variations, pharmacist licensing, and inspection readiness.

Not sure where your product fits?

Send us the manufacturer details and product specification. We'll come back with a classification opinion and registration roadmap.