ISO 9001 
ISO 17100 
ISO 18587 LinguaVox provides pharmaceutical translation services for pharmaceutical companies, regulatory teams, CROs, laboratories and medical communication agencies. We manage multilingual projects in more than 150 languages, combining specialist translators, project management, terminology control and review workflows according to what each assignment requires.
Translation for the pharmaceutical sector
Pharmaceutical content combines regulatory wording, scientific terminology and strict internal consistency. Much of it follows templates and controlled vocabularies — product information often has to match EMA QRD templates, and standard terms for dosage forms and routes of administration come from EDQM references — so the translation must fit established structures rather than read as free prose. Translation memories and glossaries are useful from the first assignment, because consistency between a summary of product characteristics, its package leaflet and the labelling is part of the requirement, not an optional refinement.
For that reason we do not assign work on language pair alone. The document type, the target reader, the destination market, the format and the level of review all shape the workflow.
Documents we translate
Typical documents include summaries of product characteristics (SmPCs), package leaflets, labelling and artwork text, regulatory submissions, pharmacovigilance reports such as ICSRs and periodic safety reports, quality and manufacturing documentation, clinical trial material and product monographs. Some support marketing authorisations, some support safety reporting, and some are internal quality records. Each use case changes the level of care and the type of review required, and many have to be produced in the national languages of every market where the product is authorised.
Before quoting, we review the files whenever possible to identify non-editable text, tables, repetitions, embedded artwork, multilingual layouts, versioning issues and instructions that should be applied during translation.
Specialist translators and quality control
Projects are assigned to translators with pharmaceutical or regulatory subject-matter experience and the right language combination. Where the assignment includes bilingual revision, a second qualified linguist checks the translation against the source, and the project manager reviews files, instructions and delivery format before completion. For regulated documents we can also support query management, so questions about source ambiguities are resolved consistently across all languages.
This supports ISO 17100-based workflows for professional translation. For large volumes of suitable content, full post-editing of machine translation may be considered, but regulatory and patient-facing pharmaceutical content is normally translated by humans with revision.
Terminology and version control
Few sectors depend on terminology control as heavily as pharmaceuticals. Approved terms, product names and standard phrases must stay identical across documents, languages and successive submissions. We manage this with translation memories, glossaries, controlled reference terminology and structured delivery, so that an update to one document can be reflected accurately across every affected language version without reintroducing inconsistencies.
Submissions, artwork and delivery
Pharmaceutical translation usually runs against regulatory timelines, so predictable delivery matters as much as the translation itself. We coordinate the national languages each market requires, deliver in stages where a submission is phased, and keep a consistent file structure across languages so reviewers and regulatory affairs teams can navigate the set. Labelling and leaflet text often has to fit fixed artwork, so we work with the relevant formats — including editable PDF, XML and InDesign — and can return translations ready to be placed, with desktop publishing quoted separately. We also support proofreading of laid-out artwork, where a final check confirms that the placed text matches the approved translation and that nothing has been truncated or reflowed incorrectly. Across all of this, the same controlled terminology and translation memory are applied, so that what was approved in one cycle is reused accurately in the next rather than re-translated from scratch. For companies managing a portfolio of products across many markets, this is where a translation partner earns its place: not in any single leaflet, but in keeping hundreds of related documents consistent, traceable and quick to update as labels, indications and safety information change over time.
Related services
Pharmaceutical translation often connects with medical and clinical research translation, legal and certified translation, regulatory writing support, desktop publishing for leaflets and artwork, and terminology management. The right combination depends on the files and on how the content will be used.
How to request a quote
To prepare an accurate quote, send the files, the language combination, the deadline, the destination markets and the intended use, with any previous translations, glossaries, templates or style guides. For large multilingual submissions we can organise staged deliveries, separate files by language and follow a consistent structure across markets, so translation fits into your regulatory timelines.
Frequently asked questions
Do you work with EMA QRD templates and EDQM Standard Terms?
Yes. We can align product information with QRD template structures and use EDQM Standard Terms for dosage forms and routes of administration where they apply, so the translation fits the expected format. Share the template version and any reference terminology you require.
Can you keep SmPC, leaflet and labelling consistent with each other?
Yes. These documents share a great deal of wording, so we use a translation memory and glossary to keep terms identical across all three and across languages. This also makes later updates faster and reduces the risk of inconsistencies between versions.
Do you handle pharmacovigilance documents?
Yes. We translate safety content such as individual case safety reports and periodic safety reports, working to controlled terminology and tight consistency. Tell us the document types, volumes and turnaround expectations and we will propose a suitable workflow.
Can you support multi-country regulatory submissions?
Yes. We coordinate the same source content across the national languages required for each market, keep terminology aligned and can deliver on a staged schedule to match submission deadlines. We confirm the language list and timeline before starting.
Is machine translation used for pharmaceutical content?
Only where it is appropriate. Regulated and patient-facing documents are normally translated by specialist human translators with bilingual revision. For some high-volume, lower-risk internal content, post-editing of machine translation may be an option, which we would discuss with you first.
