Precision Medical Translations for Global Healthcare Compliance & Patient Safety
Accurate, specialized translations drive innovation in life sciences. Trust expert linguists to convey complex research with clarity, ensuring global impact and compliance.
Impeccable quality translations for FDA/EMA submissions. Our solid expertise and AI-powered solutions ensure 100% accuracy in clinical trial protocols and medical device documentation.
With extensive experience across 30+ therapeutic areas, we deliver competitive conditions for pharma translations. Edge tech tools maintain consistency in complex scientific terminology.
Flexible and effective client service for urgent projects. From patient informed consents to CSR summaries, we combine deep expertise with rigorous quality controls.
Medical Translation Excellence Saves Lives Globally
Clinician-Led Precision for Pharmaceutical, Device and Clinical Trial Documentation Worldwide
In life sciences and healthcare, linguistic precision is a matter of patient safety and regulatory compliance. Oris Translations delivers medically-certified translations through a unique combination of practicing clinician-linguists, pharmaceutical-grade quality systems, and secure technology infrastructure to ensure absolute accuracy in global medical communications.
Clinical-Grade Translation ExpertiseMedical translation demands dual expertise in healthcare and linguistics that few providers can deliver. Our team consists of actively licensed physicians and PhD researchers who specialize in translating critical documents, from clinical trial protocols to surgical robotics manuals. These professionals work alongside regulatory experts to maintain strict adherence to FDA, EMA, and ICH-GCP standards throughout the translation process. Every document undergoes rigorous scientific and linguistic validation to preserve meaning and compliance. The result is translation work that pharmaceutical companies, medical device manufacturers, and research institutions trust for its technical accuracy and life sciences-specific terminology precision.
Compliance-Driven OutcomesThe consequences of medical mistranslation extend beyond linguistic errors to potentially life-threatening situations. Oris Translations mitigates these risks through ISO 13485-certified workflows designed specifically for healthcare content. Our process ensures proper dosage instructions, accurate device specifications, and unambiguous clinical trial documentation across all languages. We implement enterprise-grade security protocols to handle sensitive patient data in compliance with HIPAA and GDPR requirements. From accelerating drug approvals to preventing treatment errors, our translations support better patient outcomes worldwide while helping life sciences organizations maintain compliance across international markets and regulatory environments.
Regulatory Mastery in Medical Translation
We adapt patient materials with cultural sensitivity—informed consent forms, drug labels, and telehealth content—using health literacy principles. Our translations undergo HCP review to ensure clarity and accuracy for diverse populations, from clinical sites to end-users.
6 REASONS TO CHOOSE ORIS TRANSLATIONS
Trusted translation partner for global healthcare innovation
In an industry where precision saves lives, Oris delivers scientifically accurate, compliant translations. Our specialized solutions empower pharmaceutical, biotech, and medical device leaders to communicate safely across global markets.
Unmatched Regulatory Expertise
Oris linguists are trained in FDA, EMA, and ICH guidelines, ensuring submissions meet exacting standards. We maintain 100% compliance for clinical trial documentation, drug applications, and device labeling across 120+ global markets.
Subject-Matter Specialist Linguists
Our team includes PhD researchers, practicing physicians, and former regulatory reviewers. They precisely translate complex concepts—from pharmacokinetics to surgical protocols—with proper terminology in all target languages.
Patient-Safety Focused Approach
We implement triple verification for patient-facing materials (informed consents, medication guides). Each translation undergoes medical, linguistic, and local HCP review to prevent dangerous misinterpretations in any language.
Secure Data Protocols
With HIPAA-compliant workflows and ISO 27001 certification, we protect sensitive data. Our encrypted platforms and strict access controls ensure complete confidentiality for preclinical studies and proprietary research.
End-to-End eCTD Solutions
From nonclinical to CMC sections, we handle full eCTD submissions. Our XML-aware systems maintain document structure while translating, ensuring seamless regulatory acceptance in all target countries.
Rapid Response Capabilities
Urgent pharmacovigilance case reports? We deliver 24/7 with 99.9% on-time accuracy. Our dedicated life science teams and AI-assisted tools process time-sensitive documents without compromising quality or compliance.
Precision solutions for global healthcare communication
In the life sciences, specialized translation ensures patient safety and regulatory compliance. Oris delivers accurate, culturally adapted translations across six critical areas, following rigorous processes tailored to each document type and therapeutic field.
Life Science Translation Specializations
Precision solutions for global healthcare communication.
In the life sciences, specialized translation ensures patient safety and regulatory compliance. Oris delivers accurate, culturally adapted translations across six critical areas, following rigorous processes tailored to each document type and therapeutic field.
Trusted Partner for Global Healthcare Translation Excellence & Compliance
Precision Medical Translations for Borderless Healthcare Innovation
With clinician-linguists and regulatory-certified processes, we ensure error-free translations for global healthcare—where every word protects patients, accelerates approvals, and advances medical progress without compromise.
Clinical Trial Documentation
Process: Our 3-step validation (medical translator → therapeutic-area specialist → QA) ensures perfect accuracy for protocols, CRFs, and patient narratives. We align with ICH-GCP standards and maintain audit-ready translation memories for multi-phase trials.
Regulatory Submissions
Process: Using eCTD-compatible tools, we translate drug dossiers (Module 2-5) with terminology validation against FDA/EMA databases. All submissions include certification of accuracy for regulatory acceptance across 50+ markets.
Medical Device Labeling
Process: After extracting source content, our ISO 13485-certified team translates and formats labels/IFUs, then verifies against EU MDR/21 CFR Part 801 requirements. Bilingual engineers confirm technical accuracy.
Pharmacovigilance Materials
Process: Urgent ICSRs are prioritized, with AI-assisted translation reviewed by pharmacologists within 4-hour SLA. We maintain MedDRA-compliant terminology databases for consistent adverse event reporting.
Patient-Facing Materials
Process: Transcreated content undergoes health literacy review (≤8th grade level) and cultural adaptation by native-speaking HCPs, ensuring informed consents and medication guides are both accurate and accessible.
Scientific Publications
Process: Journal-submission ready translations include statistical review by PhDs, proper SI unit conversion, and formatting per ICMJE guidelines. We guarantee plagiarism-free, publication-quality manuscripts in all languages.
Request Your Specialized Life Science Translation Quote Today
Trust Oris’ 15+ years of life science expertise for accurate, compliant translations. Our subject-matter specialists and secure workflows deliver reliable results. Contact us for competitive pricing and tailored solutions that meet your exact regulatory and clinical needs.
Precision Matters: Life Science Translation Questions Answered
Expert Solutions for Clinical, Regulatory, and Medical Device Linguistic Challenges
In life sciences, every word carries weight. This chapter addresses critical questions about medical translation, showcasing how Oris Translations combines clinical expertise with rigorous processes to ensure accuracy in trials, devices, and drug development. Discover best practices that protect patients, maintain compliance, and advance global healthcare innovation.
Certified Medical and Pharmaceutical Language Solutions
We deliver impeccable quality translations with solid, extensive experience in life sciences. Our AI-powered solutions and edge tech tools ensure precise, compliant documents under competitive conditions for global markets.
Where Machine Efficiency Meets Human Expertise
Request Your Specialized Life Science Translation Quote Today
Trust Oris’ 15+ years of life science expertise for accurate, compliant translations. Our subject-matter specialists and secure workflows deliver reliable results. Contact us for competitive pricing and tailored solutions that meet your exact regulatory and clinical needs.