Patient safety & EMA/FDA compliance without compromise
From Phase I clinical trials to instructions for use. Translation by healthcare professionals and scientists (MD/PhD).
In 30 seconds
- MD/PhD translators: Bilingual physicians, pharmacists and biologists with specialist nomenclature expertise.
- GDPR / HIPAA compliance: Anonymisation, secure protocols, full protection of health data.
- Regulated documents: Marketing authorisations, medical devices (IFU), ICF, CSR, hospital emergency protocols.
- JCI / ICH network: Scientifically validated glossaries for global launches across 150+ target languages.
Medical linguistics: where approximation is a mortal risk.
The problem in the life-science industry is that a single dosage conversion error or the passive distortion of a contraindication turns a patient information leaflet into a serious health risk and legal liability for the manufacturer.
The Asiatis solution: outsource scientific linguistics to healthcare-professional translators (MDs, PharmDs). They command both the terminology registers (MedDRA, ICH guidelines) and validate each occurrence scientifically rather than processing isolated words.
AI (MTPE) advisory: Patient safety is our red line. The use of neural machine translation is strictly prohibited for marketing authorisations, IFU and diagnostics. The human expert remains the sole decision-maker.
Ensure the safe and effective use of your products worldwide.
Clinical Protocols & Devices
Clinical Trials (CRO)
Informed consent forms (ICF), clinical study reports (CSR), case report forms (CRF), safety reports (SAE/SUSAR) adapted for patients and ethics committees.
Regulatory Submissions (EMA/FDA)
eCTD submission dossiers, modules 2–5, summary of product characteristics (SmPC), periodic safety update reports (PSUR).
Medical Devices (MedTech)
Imaging equipment manuals (MRI/CT), CE marking documentation (MDR 2017/745), software as a medical device (SaMD), surgical brochures.
Technical standards →Fundamental Research & Hospital
Molecular biology, academic publications, post-operative guides, repatriated patient records.
Scientific rigour allows no margin for error
Our Life Sciences–specific QA protocol.
Profile assignment
Strict selection of the working pair: one MD for clinical logic plus one native linguist.
MedDRA alignment
Injection of your glossaries and regulatory terminology databases (EMA/FDA).
Dual LSO review
Cross-review. Metric values, numerical data and dosage figures are isolated and verified separately.
Final validation
Delivery and secure erasure of patient health data in accordance with HIPAA procedures.
Uncertain about the regulatory framework for your target market?
Medical pricing structure
Health Brochure / Patient Information
General health content, patient-facing materials. E.g. newsletters, health blogs.
Per-word billing
Clinical Study / Pharmacovigilance
Complex protocol, high-precision. Specialist MD/PhD translator.
Per-word billing
Certified & Sworn Translation
Medical records validated for court proceedings or foreign administrative procedures.
NDA applicable upon receipt of documents. Average throughput: 1,500+ words/day/translator.
Frequently Asked Questions
Are your medical translators qualified?
Do you comply with JCI and regulatory standards (FDA, EMA)?
Do you offer MTPE post-editing for medical documents?
How do you guarantee data confidentiality (GDPR / HIPAA)?
Leave no clinical gap to chance.
Obtain a surgically precise translation ready for submission to global health authorities. Strict confidentiality guaranteed.
Paris (Europe Quarter) — Montréal — Singapore