Regulated Medical Translation Services for Health Canada, Clinical Trials, and Medical Devices
Asiatis supports pharmaceutical companies, medtech, CROs, university hospitals, and medical associations with the professional translation of their regulatory, clinical, technical, and scientific documents in Canada.
Trusted by leading institutions
The Canadian medical market requires precise, consistent documentation adapted to the bilingual EN/FR context.
Regulatory, clinical, and technical documents cannot be translated like general content: terminology, consistency, confidentiality, and traceability are critical.
Asiatis acts as a specialized translation partner, with experienced medical translators, confidentiality processes, and client-specific terminology management.
Disclaimer: Asiatis provides translation and linguistic adaptation services; final regulatory interpretation is the responsibility of the sponsor, manufacturer, regulatory consultant, or legal counsel of the client.
Health Canada Submissions
DIN, NPN, product monographs, package inserts, labelling, response documents, and regulatory correspondence.
Clinical Trials & Consent
Informed consent forms, protocols, investigator brochures, patient materials, site communications, and ethics committee documents.
Medical Devices
IFUs, user manuals, labelling, technical documentation, vigilance, recalls, and training materials.
Pharmacovigilance
CIOMS, ICSR, PSUR/PBRER, dear healthcare professional letters, and safety communications.
Publications & Research
Scientific articles, abstracts, conference posters, practice guidelines, and continuing medical education.
Hospital & Patient Communications
Patient brochures, care consent documents, multilingual communications, and educational materials.
Supported Documents
| Document Type | Target Audience | Specificities |
|---|---|---|
| Product Monograph | Healthcare Professionals, Health Canada | Strict terminology, standardized format |
| Informed Consent Form | Patients, Ethics Committees | Clear and accessible language (plain language) |
| IFU / Medical Device Manual | Users, Technicians, Patients | Technical precision, regulatory compliance |
| CIOMS Report / Pharmacovigilance | Regulatory Authorities | Strict deadlines, MedDRA coding |
| Patient Brochure | General Public, Patients | Medical popularization, empathy |
| Scientific Article | Researchers, Physicians | Academic rigor, international publication |
| Clinical Practice Guideline | Healthcare Professionals | Updating of care protocols |
| Medical Training Material | Medical Staff, Representatives | Pedagogy and scientific accuracy |
A Process Designed for Regulated Environments
- Selection of specialized translators in medical/pharma/medtech
- Client-specific controlled terminology
- Dedicated translation memory
- Specialized proofreading
- Version management
- Traceability of deliveries
- Emergency management
Confidentiality of Medical and Regulatory Data
- Files treated with strict confidentiality
- Access restricted to necessary resources
- Documents transmitted and archived according to agreed procedures
- Possibility of bilateral NDAs upon request
- No client mentions without explicit authorization
- Adaptation to internal compliance requirements
Why Choose Asiatis?
Asiatis has worked for over 25 years with players in the pharmaceutical, medtech, hospital, scientific, and institutional sectors in Canada and internationally.
Medical & Pharmaceutical Experience
Proven expertise in the healthcare fields.
International Linguistic Network
Teams capable of managing multilingual projects.
EN-CA / FR-CA Expertise
Mastery of Canadian linguistic specificities.
B2B Project Management
Processes designed for recurring volumes and long-term partnerships.
Frequently Asked Questions
What is the difference between medical, pharmaceutical, and regulated translation?
Medical translation covers a broad spectrum, including patient information. Pharmaceutical translation focuses on drugs. Regulated translation is specifically tailored to the requirements of authorities like Health Canada, requiring controlled terminology and strict traceability.
Do you translate documents intended for Health Canada?
Yes, we regularly translate product monographs, response documents, and submission files for Health Canada, strictly adhering to their terminology guidelines.
Can you translate informed consent forms for clinical trials?
Absolutely. We translate informed consent forms (ICF), protocols, and investigator brochures, ensuring clarity for patients and scientific accuracy for professionals.
Do you work with medical device manufacturers?
Yes, we assist medical device manufacturers with the translation of instructions for use (IFU), labelling, and technical documentation in compliance with regulations.
Are your medical translations certified?
We can provide certified translations by sworn/certified translators when required by regulatory authorities or ethics committees.
How do you ensure the confidentiality of medical documents?
We apply strict security protocols, sign non-disclosure agreements (NDAs), and manage documents on secure platforms. Access is restricted to essential project personnel.
Can you handle recurring volumes or multi-document programs?
Yes, we deploy dedicated translation memories and client-specific glossaries to ensure terminological consistency across large volumes and ongoing projects.
What is the turnaround time for a regulated medical project?
Turnaround depends on volume and complexity. Regulated translations require thorough review stages. We also offer expedited processes for clinical trial or pharmacovigilance emergencies.
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