LANGUAGE · VERSIONSSYNTHETIC DATARA LEAD · DRUG
Language Versions & Labeling
Artwork and pack inserts drafted by machine, certified by a qualified expert before submission.
Machine-Assisted, Expert-Certified
Only a small portion of the dossier is translated — artwork and pack inserts, and a few annexes. It has to be a certified translation done by someone who understands the technical meaning, and it takes months today. A pharmacology and regulatory ontology carries the terminology; the expert still signs, so months become days.
IN QUEUE
11
LANGUAGES
8
CERTIFIED
4
Language Artefacts
Drafted by machine, certified by a qualified expert. An uncertified draft cannot be attached to a submission.
ARTEFACT
LANGUAGE · MARKET
DRAFT
CERTIFIER
STATE
Carton and pack insert
Vietnamese · Vietnam
0.94
Local RA + certified
REVIEW
Carton and pack insert
Thai · Thailand
0.96
Bangkok RA + certified
REVIEW
Artwork, full pack
French · West Africa
0.91
External certified
DRAFT
Product information leaflet
Bahasa · Indonesia
0.90
External certified
DRAFT
National permit annex B
Spanish · Peru
0.97
LATAM desk
CERTIFIED
Labelling declaration
Ukrainian · Ukraine
0.88
External certified
DRAFT
Pack insert
Khmer · Cambodia
0.86
External certified
DRAFT
Terminology Ontology
Controlled equivalents, not free translation. A term enters the ontology only once an expert has signed it, and then it is reused across every artefact.
Related substancesANALYTICAL
Locked equivalents in 6 languages. Never rendered as “impurities” — the two are not interchangeable in a specification.
Modified releaseDOSAGE FORM
Distinguished from sustained, prolonged and extended release per each market's own nomenclature list.
Shelf lifeSTABILITY
Bound to the market's definition of the storage condition it is claimed under.
BatchMANUFACTURING
Separated from lot where the market treats them as distinct regulatory objects.
Qualified personGMP
Role name resolved per jurisdiction; not translated literally where no equivalent role exists.
Pack insertLABELLING
Kept distinct from patient information leaflet and from summary of product characteristics.
Turnaround By Market
Certified translation used to sit on the critical path. These are the current cycle times against the manual baseline.
Vietnam — Vietnamese6 days
WAS 14 weeksExternal certified expert
Peru — Spanish4 days
WAS 11 weeksIn-house, certified
Myanmar — Burmese11 days
WAS 16 weeksExternal certified expert
Uzbekistan — Uzbek14 days
WAS 18 weeksExternal, sole provider
Ethiopia — Amharic9 days
WAS 13 weeksExternal certified expert
Cambodia — Khmer12 days
WAS 15 weeksExternal certified expert
Certification Gate
A draft cannot be attached to a submission. These are the four checks between machine output and a filed artefact.
01Terminology check against the ontologyAutomated — flags any term without a signed equivalent.
02Alignment to the approved source textAutomated — diffs against the version actually approved.
03Technical read by a qualified expertHuman — pharmacology and regulatory meaning, not grammar.
04Certification signatureHuman — the artefact becomes filable only at this point.
Artwork is the one artefact where a wrong word is a recall, so the gate never shortens.
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.