Skip to content

Guide

How to Start a Cold-Chain or Pharmaceutical Logistics Company

The short answer

A medical warehouse in the UAE is licensed by the Emirates Drug Establishment (EDE), which describes itself as the only federal authority regulating medical and pharmaceutical products. EDE issues two types: import or distribution, and re-export. Food storage and transport fall to the municipality, such as Dubai Municipality. A trade licence for refrigerated storage opens the company and nothing more. The product list decides the route.

Who decides what

Three questions sit under one business name. Which products may you hold? Is the building approved for them? Is the company licensed for the activity? Different bodies answer each.

EDE describes its scope as medical and pharmaceutical products, medical devices and other regulated product groups, and lists registration, market authorisation, pharmacovigilance and inspection among its services. For a logistics company the point is that product regulation does not stop at the manufacturer. Ask EDE and MOHAP which approvals a storage and transport operator needs for the product classes you intend to hold, and whether those depend on the emirate.

For food, Dubai Municipality states that it maintains standards for food and consumer goods through inspections and compliance. Ask the municipality for your site what the food premises requirements are for cold storage and for vehicles.

The product matrix first

Write down every product family, its storage range, its owner and its regulator. Frozen, chilled, controlled room temperature and ultra-cold are different operations, and food, medicines and devices are regulated by different bodies. One setpoint for all products is a common mistake, and an inspector reading temperature logs will see it at once.

The matrix also decides what you refuse and which partners carry what. Qualified carriers can move specific product classes. A pharmaceutical operation with its own quality system may need to sit in a different entity from general food logistics, because mixing audit regimes means every customer audits everything. For the customs side of cargo arriving by air or sea, read the guide on a bonded-warehouse or re-export logistics business.

Qualification, monitoring and roles

Regulated customers will not wait for a licence. They audit. A pharmaceutical customer expects evidence that the facility was qualified, that temperature was mapped across the space, that monitoring equipment is calibrated, that alarms reach a person who can act, and that vehicles and packaging were qualified for the routes used. Keep this as a file, dated and signed, not as a set of intentions.

Data loggers are not a quality system. The system is the procedures, the training, the change control, the deviation handling and the people who own them. Name the quality role and the responsible person for each regulated product class early, and confirm with EDE or the relevant regulator what the role must hold and where the person must be based. These hires are a cost the licence fee does not show.

Decide the excursion process before a customer asks for it. When a reading leaves its range, who assesses the product, on what data, and who decides whether it can be used? Leave that to the customer in an informal email and a dispute follows. Put the process in the quality agreement.

Structure, location and money

The entity that signs the quality agreements should own the qualified facility, the monitoring systems and the trained people those agreements assume. Vehicle or property companies can sit elsewhere in the group with genuine roles. The choice between a mainland company and a free-zone licence follows the product flows. Airport-adjacent sites can suit pharmaceutical transit, but facility approval and product permissions follow the goods wherever the building stands, and domestic distribution raises its own questions.

A bank reads this plan as a capital and liability question: costly plant, perishable cargo and losses that arrive in full. Prepare the product and temperature matrix, the facility and vehicle qualification plan, the monitoring and alarm design, the quality agreements and procedures, and the excursion, recall and continuity plans. Show the insurance cover against the values you will hold. Where bank onboarding is the sticking point, the work on corporate bank account readiness covers how the file is built. A coherent file reduces questions. It does not guarantee an account.

What commonly goes wrong

  • Capital before qualification. A freezer hall is built and vehicles bought before the product matrix showed what needed qualifying.
  • One setpoint for everything. A single temperature is used across products with different ranges.
  • Loggers mistaken for a system. Monitoring equipment is treated as the whole quality system.
  • Excursions left to the customer. There is no contractual process for deciding what happens to product that left its range.
  • Cost read as the licence fee. Plant, redundancy and insurance dominate. The cost depends on the route and the product risk, and Velarozone's own fee is itemised in the engagement letter, as explained in how Velarozone works.
Container terminal and cranes at a Dubai port

General guidance here; the detail that matters depends on your activity and markets.

Questions

Frequently asked

Do I need EDE approval to store medicines?
Yes. EDE licenses medical warehouses, in two types: import or distribution, and re-export. The process runs through a primary inspection and a final inspection, and needs a responsible pharmacist licensed by MOHAP. Confirm the current steps with EDE before you lease or build.
Can one warehouse hold food and medicines?
Different regulators and quality expectations apply to each. Even where the building allows it, many operators separate them to keep each audit clean. Decide with the product matrix in hand.
Who decides if a shipment that went warm can be used?
The quality agreement should say. In practice the product owner or the person responsible under its quality system decides, on data you supply. Agree the data, the timing and the decision-maker in advance.
Can I use partners for transport?
Yes, if they are qualified for the product class and the route. Your quality agreement then covers how you qualify and monitor them, and who answers when a vehicle fails.

Get your UAE setup plan

Velarozone starts from the product matrix, then maps the approvals, qualification work and quality roles that stand between registration and your first regulated consignment. Begin with what you will store:

Apply this to your own situation

Guides describe the general position. Send us your facts and an adviser will tell you which parts actually apply to you.

Message us on WhatsApp

Free assessment: current figures are confirmed within your adviser-reviewed route comparison. Your details are not shared with third parties.

Start with a structure assessment

In an initial consultation you receive a plain-language decision summary, a document-preparation list, and the next actions for your situation. Current figures are confirmed within your adviser-reviewed route comparison.

This guide provides general information, not legal, regulatory, tax, investment or financial advice. It does not guarantee a licence, authorisation, visa, bank account, funding or tax outcome.

General information drawn from the CBUAE Rulebook, including the Retail Payment Services and Card Schemes Regulation (C 15/2021), and Cabinet Resolution No. (134) of 2025 as published, not legal or tax advice. Rules and guidance change, so confirm the current text and each institution's own requirements before you submit.