The regulator reads every word. We write every one for them.
That's why every page leaves us audit-ready: who translated, who reviewed, which terminology, which version. Full traceability across MDR, IVDR, EMA and Infarmed, from trial protocol to the leaflet the patient reads.
MDR, IVDR, EMA, FDA, ANVISA: every market has its own evolving rules. One failed requirement means rejected submissions, fines or delays of 6 to 18 months.
✓
Triple-certified workflows (ISO 9001 · 17100 · 18587), adapted to each jurisdiction, with compliance checks at every stage.
02
Content where one term changes everything
From trial protocols to patient leaflets, the documentation is dense and imprecision compromises safety, and your credibility with the notified body.
✓
Native linguists from the medical and pharmaceutical fields, glossaries validated with you, and EDQM/MedDRA terminology applied and verified.
03
Regulatory deadlines with no margin
Submission windows, certification renewals, responses to requests for clarification: speed cannot come at the cost of precision.
✓
Expert-supervised AI: ISO 18587-certified post-editing plus multi-layer QA, for high volume on short deadlines.
04
Patient data and proprietary formulas
The content is sensitive by nature and must remain secure in all circumstances; auditors ask about this too.
✓
Strict GDPR compliance, teams under NDA, encrypted transfer, data residency on request, and no public translation engines.
What we translate in this sector
01
Regulatory & legal
Regulatory submissions (MDR, IVDR, EMA, ANVISA)
CTD/eCTD dossiers and variations
SmPC, labelling and QRD templates
Responses to requests for information
02
Technical & quality
GMP SOPs and manufacturing procedures
Process validation reports
Certificates of analysis
Pharmacovigilance documentation (PSUR)
03
Clinical & patient
Instructions for use (IFU) and patient leaflets
Clinical trial documentation
Medical device labelling and packaging
Does your content need more than translation?Explore our specialised human translation and independent LQA services.
Regulatory analysis, medical specialists, validated terminology and a dossier ready for the auditor.
1
Regulatory analysis
Target markets, risk class, MDR/IVDR/EMA requirements and submission deadlines
2
Specialised translation
Native linguists from the medical and pharmaceutical fields, with your glossary
3
Verified terminology
EDQM and MedDRA applied and verified; consistency across the dossier's documents
4
Review + back-translation
Independent second specialist; back-translation for safety-critical content
✓
Audit-ready dossier
Consolidated LQA and full traceability: who translated, who reviewed, which version
CASE STUDY
Life Sciences & PharmaceuticalsCLIENT: Portuguese pharmaceutical company · INFARMED · EMA · COMPLETED ✓
450,000 words. 3 markets. 18 days. No delays
A Portuguese pharmaceutical company needed the impossible for a submission. We delivered an hour early.
01
Analysis and planning: risk mapping and priorities per document, target markets and language pairs
02
Specialised native teams working in parallel, with a single validated glossary and shared translation memories
03
Independent review plus consolidated LQA by the Quality Manager, with full traceability
“What impressed us most was the calm and confidence they conveyed throughout the whole process.”Head of Regulatory Affairs · Portuguese pharmaceutical company
0.012%post-delivery revision rate (54 adjustments in 450k)
18 daysfor 450,000 words across 3 markets
Awards & certifications
Frequently asked questions
Q1How do you ensure MDR/IVDR compliance and full traceability?
We use documented, auditable workflows with change control, version-controlled documents and review by in-country experts. Every file carries an audit trail (who, when, which changes) and LQA scores, with CAPA actions whenever needed.
Q2Do you offer back-translation for safety-critical content?
Yes. Back-translation is performed by two linguists, with reconciliation notes and divergence analysis. Any semantic deviation is flagged and the approved wording is recorded in the term bases for future updates.
Q3How do you keep patient data secure?
GDPR-compliant processing, encrypted transfer, least-privilege access, teams bound by confidentiality agreements and no use of public machine translation. Data residency options are available on request.
