Medical & Pharmaceutical Translation
Scientific rigor and regulatory compliance for life sciences.
Who We Serve
Our Specialized Services
Clinical Trials
Protocols, investigator brochures, ICFs. Clarity for patients, precision for researchers.
Regulatory Affairs
MAA dossiers, labeling, package inserts. Compliance with Health Canada, FDA, EMA.
Medical Devices
IFUs, software UI, marketing materials. Adherence to safety standards.
Pharmacovigilance
SAE reports, PSURs, post-market safety documentation.
Clinical Trial Translation Types
| Document | Precision Level | Recommended Process |
|---|---|---|
| Study Protocol | Scientific Expert | Trans + Expert Review |
| Informed Consent (ICF) | Layman Language | Trans + Back-Translation |
| Investigator Brochure | Strict Terminology | Trans + QA |
| Clinical Report (CSR) | Regulatory | Certified Translation |
Technical Glossary
Back-translation
Reverse translation process to verify semantic accuracy, crucial for patient forms.
Product Monograph
Official scientific document describing a drug's properties and dosage.
CRO
Contract Research Organization providing outsourced research services.
Marketing Authorization
Official approval to market a drug in a specific jurisdiction.
MedDRA
Standardized medical terminology for regulatory activities.
Before Ordering
- Do you have a terminology glossary?
- Is the source file the final version?
- Do you need a certificate of accuracy?
- Target audience: Patients or Doctors?
Why Asiatis?
Subject Matter Experts
Translators with MD, PhD, or PharmD degrees.
Full Compliance
Strict adherence to Health Canada/FDA guidelines.
Confidentiality
Secure protocols and systematic NDAs.
Medical FAQ
Do you perform back-translation?
Yes, it is standard for sensitive docs like ICFs to guarantee perfect meaning.
Accepted by Health Canada?
Absolutely. We strictly follow their terminology and formatting guidelines.
Data confidentiality?
We use secure platforms and all collaborators sign strict NDAs. We advise anonymizing patient data.
Protocol amendments?
We use translation memories to only charge for new text, ensuring consistency and lower costs.
Get Your Free Quote
Email us your documents directly for a quick analysis.
To receive a precise offer within one hour, please send your files to:
web@asiatis.ca