The Sequence
Entity, premises, facility licence, clinician licences and payer empanelment, in the order each regulator demands.
A clinic signs a lease, then learns the premises need a layout approval that takes the fit-out budget with it. A manufacturer files a product with the Emirates Drug Establishment before the importer is appointed and loses four months. The readiness pack is the sequence for your facility or product, with every document, fee and approval in the order the regulator expects it, written by the people who will lodge the application if you ask them to.
Fixed fee. AED 25,000 for a single facility or product family; up to AED 60,000 for a group, a multi-emirate footprint or a product portfolio. Scoped in writing before we start.
Who engages this
Doctors and investors opening a first clinic or day-surgery centre in Dubai, Abu Dhabi or the Northern Emirates. Operators adding a site under a second regulator. Pharmaceutical and device companies registering a first product with the Emirates Drug Establishment, or a UAE-registered product with the SFDA in Saudi Arabia. International entrants deciding between a free zone and the mainland before anything is signed.
The work
Entity, premises, facility licence, clinician licences and payer empanelment, in the order each regulator demands.
Every document, attestation and translation, with who issues it and how long it takes to obtain.
Government fees stated from the regulator's own schedule, and a dated timeline to first billed claim.
What the layout approval will test, before the fit-out contractor is paid.
EDE verification, abridged or full pathway, importer requirements, and the SFDA route for Saudi Arabia.
The pack stands alone. If you would rather we lodged the application, the pack fee is credited against that work.
On a mandate
An orthopaedic surgeon and his investor had agreed heads of terms on a Jumeirah villa for a day-surgery centre. The pack showed the premises could not meet the DHA day-surgery standard without structural work the landlord would not permit, and that the specialty they planned required an approval the surgeon's licence category did not yet carry. They walked away from the lease, took a purpose-built unit in Dubai Healthcare City instead, and billed their first claim fourteen weeks after signing, inside the timeline the pack had set.
Questions
The free steps are generic and often out of date. The pack is written for your facility type, specialty, emirate and licence category, by a regulatory team that lodges these applications, and it is dated. The cost of a wrong sequence is usually a lease payment or a month of lost billing, which is many times the fee.
Ten business days for a single facility or product family, up to fifteen for a group or portfolio. It begins with a scoping call so that the pack answers your situation and not a standard one.
For products, yes: the SFDA verification and abridged pathways for a product already approved in a reference market, and the authorised representative requirement. For facilities in Saudi Arabia we work with a local partner and say so in the pack.
Yes, in full. The pack is the first part of the filing work, so you do not pay for it twice.
If you are about to sign a lease, appoint a distributor or file a dossier, get the sequence first.
Further reading
Why UAE healthcare facility licensing under DHA or DoH must run in strict sequence, and how a stage-two decision determines what happens at stage six.
Regulatory BriefHow UAE marketing authorisation actually works under the Emirates Drug Establishment: one standard eCTD route scaled by product class, a separate 90-working-day pricing clock, and no reliance pathway for products approved by the FDA or EMA.
Market AccessWhy the free zone, mainland and DIFC or ADGM decision must be modelled against Corporate Tax and banking at establishment, not treated as paperwork.
Engagement · Limited mandates
We take a limited number of mandates at any time. If you are working a decision that needs independent counsel, start with a conversation.