Dossier readiness
We organize, review and convert CTD or paper files into a submission-ready eCTD structure, identifying gaps before filing.
Artwork and localization
Labels, leaflets and promotional materials are checked for consistency, readability and Arabic-English requirements.
A clear scope before quoting
Who this service is for
Regulatory teams, MAHs and manufacturers preparing or correcting UAE eCTD submissions, technical sequences, labelling or artwork.
Typical situations
- The dossier needs content and structure readiness review
- A sequence has technical validation findings
- Labels, leaflets or artwork require UAE/GCC alignment
Potential scope
- Dossier-content and gap review
- eCTD structure, conversion and technical validation support
- Validation-finding analysis and correction coordination
- Artwork, labelling and leaflet compliance review
Deliverables
- Readiness findings and prioritised actions
- Technical sequence or correction plan
- Consolidated artwork and labelling comments
Information needed to scope the work
- Available dossier modules and source files
- Validation reports or authority findings
- Current artwork, labels and reference text
- Submission type, jurisdiction and timing
Timing and fees
Technical validation confirms that a sequence meets applicable technical criteria; it is not regulatory approval. Automated or AI-assisted checks do not replace expert regulatory review. Fees depend on file condition, modules, sequence complexity, artwork volume and timing.
eCTD technical resource
For additional information on eCTD software and technical implementation solutions, visit Masuu Global.
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What are common dossier-readiness gaps?
EDE specifies eCTD for its drug and biopharmaceutical marketing authorization service. For a readiness review, ViaFarma recommends reconciling manufacturer, site and product details across modules and artwork, checking that evidence matches the proposed product, and running technical validation before submission.
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.