Pharma & BiologicsGetting the product to the patient, faster.
We advise pharmaceutical and biologics companies on the UAE and GCC, and that includes the regulatory pathway, which we have run to approval on live mandates. But registration is a means. The problem underneath is commercial: your product is not yet reaching the patients who need it, and every month it does not is revenue lost.
Where we are brought in
We are brought in on the decisions that set the size of the prize.
- 01
Speed to patients
A product cleared elsewhere is not yet cleared here, and the review runs long. We prepare the dossier so it moves the first time. A submission that draws major queries loses six to twelve months per cycle, and most of those queries are preventable before filing. That is the difference between a product earning and a product waiting.
- 02
Manufacturing localisation
The UAE wants a domestic pharmaceutical base, and the incentives are real. But building here is a capital commitment that has to clear its own return. We model the case against the licence programme, the zone options, and the GMP standard your export markets demand, then tell you if it holds.
- 03
Biologics strategy
Biologics carry a longer, harder pathway and a larger prize. We set which products lead, how they sequence, and where the return justifies the complexity.
- 04
Pharma M&A
Distribution businesses, manufacturing assets, and registration portfolios change hands across the GCC. The value sits where a generic advisor never checks: the status of each registration, the enforceability of the agent agreement, the compliance state of the site. We value the asset for what it actually is.
How the practice converges
Five pillars converge here. Strategy decides which products lead and how the GCC sequences. Transactions and capital run the deal and the raise. Market access opens the registration and the manufacturing licence. Operations build the quality system that keeps the plant producing. Geopolitical advisory maps the API exposure through the Gulf corridors. The regulatory ground contact (MOHAP, DHA, SFDA) was earned on approvals, not read from a manual.
On a mandate
A generic manufacturer's UAE facility licence had stalled for three years. We read the technical file, found the deficiencies holding it, remediated them, re-engaged the regulator, and prepared the inspection. The licence was granted within eighteen months. The plant that could not produce now produces.
Questions
What clients ask first.
How long does it take to register a product in the UAE?
A well-prepared file moves in twelve to eighteen months. A file that draws major queries adds six to twelve months per cycle. The pre-submission review is where that time is saved, and it is our highest-value intervention.
Does a UAE registration cover the rest of the GCC?
No. Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each run their own framework. The UAE is often the platform, but the GCC programme has to be sequenced as one plan, not market by market.
Should we manufacture in the UAE or import?
It depends on your volume, therapeutic mix, and export ambition. We model both against the actual licence timeline and cost, and give you the number, not the encouragement.
If a product is waiting or a pharma decision is unclear, start with a conversation.
Further reading
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