International manufacturers entering the UAE must demonstrate quality system maturity. We prepare your facility, documentation, and processes for the standards UAE regulators expect, and align you with international frameworks like ISO 13485, GMP, and GDP.
UAE regulators expect a controlled, documented quality system before they trust a product. Your facility, your records, and your procedures all have to stand up to scrutiny, and they have to keep doing so after approval.
We build quality and compliance as one engagement, aligning your operation with recognised frameworks such as ISO 13485, GMP, and GDP, so that your documentation and your processes move together rather than blocking each other.
A single team across manufacturing, distribution, and documentation standards.
Preparing your manufacturing facility, records, and processes for Good Manufacturing Practice expectations.
Aligning storage, handling, and distribution with Good Distribution Practice across the supply chain.
Building the medical device quality management system the standard requires, mapped to your products.
Designing a quality management system that keeps your facility, records, and processes controlled and repeatable.
Preparing the technical file and CTD or eCTD dossier that carries your quality evidence into registration.
Standard operating procedure development, internal audits, and rehearsal inspections before the real one.
Four stages, run in parallel where they can be, sequential where the standard requires it.
Review your facility, documentation, and processes against the relevant standards to map the gaps.
Set up the quality management system, SOPs, and records framework that close those gaps.
Implement the corrective actions and bring your processes into line with GMP, GDP, and ISO 13485.
Rehearse the audit, find any remaining issues, and confirm you are ready for the real inspection.
Tell us about your facility and the products you want to bring to the UAE. We will map the quality standards you need to meet, build the documentation and processes around them, and rehearse the inspection with you.
Talk to our quality team