Industries
Life Sciences Translation for the European Market
Asiatis translates life-sciences documentation into European languages for pharmaceutical companies, medical-device manufacturers and CROs operating from Singapore. Work covers clinical trial documents, instructions for use, labelling and regulatory files for EU markets under MDR, IVDR and EMA requirements. Every project is handled by life-sciences linguists and revised by a second specialist before delivery.
By Asiatis Singapore · Last updated 24 August 2026
Why life-sciences translation is different
In life sciences, a translation error has regulatory and clinical consequences, and the language plan is written into the regulation. Three constraints shape every project:
- 1
Regulation names the languages. Under the EU Medical Device Regulation (MDR) and IVDR, instructions for use and labelling must be provided in the language(s) each Member State requires — often every official language of the markets of sale. The language plan is a regulatory deliverable, not a marketing choice.
- 2
Patient-facing text has a readability bar. Informed-consent forms and patient information must be understood by non-specialists. This is why consent forms use back-translation and reconciliation to prove conceptual equivalence, a documented step regulators expect.
- 3
Traceability is mandatory. Version control, change tracking and audit trails follow ICH-GCP and ISO 14971 risk-management expectations; an untracked change to a translated protocol is a compliance finding.
What we translate
| Document type | Typical target languages | Typical constraint |
|---|---|---|
| Clinical trial protocols and amendments | Languages of the trial sites | Version traceability, ICH-GCP terminology |
| Informed consent forms (ICFs) | Language of each patient population | Back-translation and reconciliation, readability |
| Instructions for use (IFU) and labelling | Official languages required by each Member State | MDR/IVDR compliance, fixed formats |
| Regulatory submissions and dossiers | Language of the assessing authority | EMA and national terminology, deadlines |
| Pharmacovigilance and safety reports | Market languages | Controlled vocabulary, fast turnaround |
| Patient-reported outcome measures (PROMs) | Languages of the trial populations | Linguistic validation methodology |
| Package leaflets (PILs) | Official languages of the markets | Readability, EMA QRD template |
How Asiatis handles these projects
Life-sciences specialists only. Linguists working on clinical and regulatory content have life-sciences backgrounds or documented medical-translation experience. Domain assignment is not optional.
Back-translation and reconciliation. Patient-facing content such as consent forms and PROMs is back-translated and reconciled to prove conceptual equivalence, with a documented reconciliation report.
Two-linguist process. Translation followed by independent revision, with terminology aligned to EMA and standard controlled vocabularies, and a check on figures and units.
Traceability and version control. Change tracking, version identifiers and an audit trail per document, aligned to ICH-GCP and ISO 14971 expectations.
Confidentiality. Unpublished clinical and regulatory data is handled under NDA with encrypted transfer and restricted access.
Key facts
- Clinical and regulatory content is handled by linguists with life-sciences backgrounds.
- Consent forms and PROMs use back-translation and reconciliation to document conceptual equivalence.
- IFU and labelling are produced in the official languages each Member State requires under MDR/IVDR.
- Version traceability and audit trails are maintained, aligned to ICH-GCP and ISO 14971.
- Unpublished clinical data is handled under NDA with encrypted transfer.
Frequently asked questions
- Which languages does the EU require for medical device IFUs and labelling?
- The requirement is set by each Member State under the MDR and IVDR, and is typically the official language or languages of every market where the device is sold. Multi-market entry therefore means several language versions; we build the plan from your target markets.
- What is back-translation and why do consent forms need it?
- Back-translation is translating the translation back into the source language, by a linguist who has not seen the original, to prove meaning is preserved. It is standard for informed-consent forms and PROMs, where regulators require documented evidence of conceptual equivalence; discrepancies are reconciled and reported.
- Do you follow a linguistic validation process for PROMs?
- Yes. Patient-reported outcome measures are handled with forward translation, reconciliation, back-translation, review and, where required, cognitive debriefing, with the process documented for the submission.
- How do you keep versions traceable across a clinical trial?
- Each document carries version identifiers, change tracking and an audit trail, aligned to ICH-GCP expectations, so the translation history of an amended protocol can be reconstructed.
- Can you produce package leaflets to the EMA QRD template?
- Yes. Package leaflets are delivered in the required official languages and formatted to the EMA QRD template, with readability considered at the layout stage rather than after it.
Ready to start your project?
Contact our Singapore office to discuss your translation needs.
541 Orchard Road, #09-01, Liat Towers, Singapore 238881