Regulatory Services

Label, artwork and translation compliance

Labelling errors are one of the most avoidable reasons for registration delays, rejected shipments and recalls. We check that labels, cartons, leaflets and artwork meet each market’s requirements — content, language, format and consistency with the registered information.

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See deliverables

Materials Primary and secondary labels, cartons, patient leaflets, prescribing information
Typical inputs Registered information, draft artwork, target market
You receive Annotated artwork review and compliance checklist

Close-up of capsules sealed in blister packaging

Overview

About Label, Artwork & Translation

Each authority specifies what must appear on packaging and leaflets — and how. Requirements cover product name and strength, composition, storage conditions, batch and expiry formats, manufacturer and importer details, warnings, language, and increasingly serialisation or traceability features. Labelling must also match the registered dossier exactly.

We review artwork against the target market’s rules and your registered information, coordinate translations with qualified translators and help you manage changes across markets.

Use cases

When this service helps

Artwork for a new market

Check labelling before printing for a new registration.

Labelling changes

Implement safety or regulatory updates across markets.

Translations

Prepare and verify leaflets and labels in the local language.

Shipment rejections

Identify labelling causes of rejected consignments.

Scope

What the service covers

Market-specific labelling requirement checklist
Artwork review: mandatory text, format, symbols and legibility
Consistency check with the registered dossier and approved labelling
Patient leaflet and prescribing information review
Translation coordination and back-translation checks
Change management across multiple markets

Who does what

Graphic design and printing are done by your artwork studio and printers. Translations are performed by qualified translators; Globaxa coordinates and checks them for regulatory accuracy.

Why do labels get rejected at import?

Common causes are missing importer details, wrong language, storage statements that do not match stability data, and differences between the label and the registered information.

Methodology

How we work

A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.

Confirm requirementsLabelling rules for each target market.
Review artworkText, layout and mandatory elements are checked.
Translate and verifyTranslations are coordinated and checked.
ApproveA compliance checklist supports your final approval.

Deliverables

What you receive

Artwork review report

Annotated artwork with required corrections.

Labelling checklist

Requirement-by-requirement compliance record per market.

Translation package

Verified translations ready for artwork.

Technical basis

Guidelines we work to

National labelling regulationsEach authority’s legal requirements for labels and leaflets.
India: Drugs Rules, 1945Labelling provisions, plus QR-code requirements introduced for APIs and specified formulations.
ASEAN ACTRLabelling requirements within the ASEAN common technical requirements.
EU QRD templatesProduct information templates for EU-format labelling.

What we need from you

Registered or proposed product information
Draft artwork and dielines
Target markets and any local agent requirements
Existing approved labels for reference

Please share confidential information only after an NDA is in place — we are happy to sign one first.

Market and jurisdiction considerations

Language and content rules vary widely — for example French in many West and Central African countries, Arabic in GCC markets and local languages across Asia. We confirm the current rules for each market before reviewing artwork.

FAQs

Label, Artwork & Translation: frequently asked questions

Do you design the artwork?

No. We review it for regulatory compliance; your design studio produces the files.

Can you handle translations?

Yes. We coordinate qualified translators and check the translations for regulatory accuracy.

Can you review cosmetic labels too?

Yes — see Cosmetic & Consumer Product Regulatory Compliance.

Talk to us about Label, Artwork & Translation

Share your product, target market and timeline. We will review your requirement and propose a defined scope.