Pharmaceutical & Medical Device Translation
Regulatory precision for your marketing authorization files, labelling, and pharmacovigilance.
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Regulation Demands Linguistic Perfection
In the pharmaceutical and medical device industry, translation is not merely a linguistic exercise — it's a critical regulatory component. An error in a product monograph, patient information leaflet, or pharmacovigilance report can trigger a registration refusal, a batch recall, or an international safety alert. At Asiatis, your pharmaceutical documents go to translators who specialize in the medical field and work with the terminology expected by Health Canada, the US FDA, the European EMA, and ICH guidelines. We support pharmaceutical laboratories, medical device manufacturers, CROs (Contract Research Organizations), and biotech companies in all their international regulatory activities. From eCTD dossiers to Class III device labelling, through Periodic Safety Update Reports (PSURs) and Phase I to IV clinical trial protocols, we aim for strictly compliant terminology and a translation ready for authority submission.
Industry Players We Serve
Pharmaceutical & Device Documents
Marketing Authorization & Regulatory Submissions
Complete translation of marketing authorization dossiers: eCTD modules, product monographs, Summary of Product Characteristics (SmPC), and expert reports. We know the specific requirements of Health Canada (DIN format) and the FDA (NDA/ANDA/BLA).
Medical Device Labelling & IFU
Translation of labelling compliant with Canada's Medical Devices Regulations (MDR) and European MDR. IFU (Instructions for Use), primary and secondary labels, declarations of conformity, and CE certificates. We respect ISO 15223 symbols and UDI requirements.
Pharmacovigilance & Drug Safety
Translation of CIOMS forms, PSURs (Periodic Safety Update Reports), risk management plans (RMPs), and adverse event notifications. Adverse events are translated using the MedDRA terminology (SOC/PT coding) used in pharmacovigilance reports.
Clinical Trials — Phase I to IV
Protocols, CRFs (Case Report Forms), investigator brochures, informed consent forms, and Clinical Study Reports (CSR). Our translations comply with ICH E6(R2) GCP and Canadian and international ethics committee requirements.
Mastered Regulatory Framework
| Authority | Key Documents | Our Expertise |
|---|---|---|
| Health Canada | DIN, PADN, PDN, monographs, bilingual labelling | Native knowledge of Canadian format and mandatory bilingual requirements |
| FDA (United States) | NDA, ANDA, BLA, 510(k), PMA | Translators trained in FDA requirements, CFR Title 21 terminology |
| EMA (Europe) | SmPC, patient leaflet, EPAR, RMP | QRD template expertise and EMA terminology |
| ICH | CTD/eCTD, ICH E6 GCP, ICH Q1-Q14 | Direct application of ICH harmonized guidelines |
Why the Pharma Industry Chooses Asiatis
Specialized Medical Translators
Your documents go to translators who specialize in medical and pharmaceutical content and work from official terminology rather than approximations.
eCTD & IDMP Formats
We deliver in electronic formats required by authorities: eCTD, IDMP (ISO IDMP), structured XML, and proprietary regulatory software formats.
Multi-Authority Compliance
One partner for your Health Canada, FDA, and EMA submissions. Terminological consistency guaranteed across markets through our centralized regulatory glossaries.
FAQ — Pharmaceutical & Medical Devices
Do you handle eCTD submissions?
Yes, we master the eCTD format and can translate all modules 1 to 5, from the clinical summary to pharmaceutical and toxicological data.
Do your translators know MedDRA?
Yes. Adverse events and pharmacovigilance terms are translated using the MedDRA terminology.
Can you translate mandatory bilingual labelling in Canada?
It's our specialty. We master Health Canada's requirements for bilingual French-English labelling, including NHPRD and MDR.
Do you handle Class III and IV medical device documents?
Yes, including licence applications, IFUs, technical dossiers, and clinical evaluations. Our translators know GMDN classifications and UDI requirements.
What is your quality process for regulatory documents?
Systematic double review by a second pharma expert, terminological verification against our certified glossaries, final quality check, and delivery with compliance report.
Specialized pages
Confidentiality & Security
🔒 Health information protection: Asiatis handles your records under PIPEDA (federal), Law 25 (Quebec), PHIPA (Ontario) and the LSSSS (Quebec). Encryption in transit and at rest, a non-disclosure agreement signed by everyone involved. A file uploaded without an order is deleted automatically after 1 hour. After delivery, your documents are kept for 30 days — long enough to reissue or correct the translation — then deleted. Your documents are never used to train an AI model.
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