Registration strategy
We assess the product, legal pathway, local representation and dossier requirements before submission, helping clients choose a practical route to market.
Lifecycle support
Our support continues through authority questions, variations, renewals, compliance follow-up and post-approval regulatory planning.
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Read ViaFarma’s analysisA clear scope before quoting
Who this service is for
Manufacturers, brand owners, MAHs, distributors and healthcare companies planning a UAE submission, resolving a stalled pathway or managing registration lifecycle work.
Typical situations
- A product needs classification or a confirmed UAE pathway
- The dossier, manufacturer or MAH readiness is unclear
- A submission requires preparation, follow-up, variation or renewal support
Potential scope
- Classification and pathway assessment
- Manufacturer, MAH and site requirement review
- Dossier gap review, submission coordination and authority-query follow-up
- Artwork, labelling and post-approval planning where relevant
Deliverables
- Written scope and regulatory pathway
- Prioritised requirements or gap list
- Submission or follow-up plan aligned to the agreed scope
Information needed to scope the work
- Product name, category, composition and intended use
- Manufacturer, country and current approvals
- Available dossier, certificates and UAE representation status
- Target timing and known authority history
Timing and fees
Timing and fees depend on product classification, dossier condition, authority, number of products, manufacturer/MAH readiness and the depth of support required. Authority and third-party fees are identified separately. Registration approval cannot be guaranteed.
Does your product require a bioequivalence study?
Assess the likely BE requirement and suitable center options before committing to a study, and connect the technical decision with the intended registration and dossier pathway.
Explore BE Study SupportPlanning Beyond Approval
Registration is an essential and potentially complex milestone. Pricing, coverage, procurement, distribution, import readiness and post-approval obligations should be considered early rather than waiting until registration is complete.
Questions from manufacturing and regulatory teams
What should a manufacturer assess before registering a pharmaceutical product in the UAE?
For its drug and biopharmaceutical marketing authorization service, EDE requires prior MAH registration and an eligible applicant. ViaFarma recommends confirming classification and applicant responsibilities, then checking the dossier, evidence and supply plan against the intended pathway before committing to a submission date.
How we start
Share the product or scope, target authority or market, and desired timing. We will return with an initial assessment and clear next steps.