Industry Expertise
Life Sciences
Where Errors Are Not an Option
Regulatory-grade translations for pharmaceuticals, biotech, and medical devices. Every word meets FDA, EMA, and NMPA standards. Our life sciences linguists hold advanced degrees and undergo quarterly certification updates on evolving regulatory requirements.
What We Localize
Regulatory Precision, Global Reach
Clinical Trials
Informed consent forms, case report forms, protocol documents, and investigator brochures — ICH-GCP compliant.
IFUs & Labeling
Instructions for use, product labeling, packaging text — compliant with EU MDR, FDA 21 CFR, and NMPA requirements.
Regulatory Submissions
CTD/eCTD modules, IMPD, CMC documents — submission-ready translations with TMF formatting.
Patient Materials
Patient diaries, PROs, QoL instruments — culturally adapted with cognitive debriefing validation.
Full Coverage
What We Handle
FDA (United States)
IND, NDA, BLA submissions. 21 CFR Part 11 compliant translations with validated processes.
EMA (Europe)
CTD Module 1 translations. EudraVigilance-compliant pharmacovigilance documentation.
NMPA (China)
Clinical trial applications, registration dossiers, and post-market surveillance reports.
PMDA (Japan)
IFU, clinical study reports, and labeling translations meeting Japanese regulatory standards.
Capabilities
Technical Standards
Clinical Documents
Protocols, ICFs, CSRs, IBs, and patient diaries. Back-translation and reconciliation available.
Labeling & PILs
Package inserts, patient information leaflets, and SmPC translations with regulatory formatting.
Regulatory Submissions
CTD/eCTD modules, variation applications, and annual safety reports.
Why Orsel
Where Errors Are Not an Option
Life sciences translation is our highest-stakes discipline. Every linguist on our pharma team holds a life sciences degree and undergoes quarterly certification updates on evolving regulatory requirements.
We maintain validated translation memories and terminology databases across all major regulatory domains, ensuring consistency across trial phases and submission cycles.
Our quality system follows ISO 17100:2015, with full back-translation capabilities and reconciliation workflows for high-risk content.
ISO Certified quality management
Clinical trials supported
Regulatory rejections due to translation
Emergency protocol turnaround
Why Clients Choose Orsel
How We Solve Your Pain Points
Clinical Trial Documentation
Protocols, ICFs, CRFs, CSRs, and patient diaries — translated with full regulatory compliance. We follow ICH E6(R2) GCP guidelines and maintain consistency across trial phases.
Regulatory Submissions
CTD/eCTD modules, SmPCs, PILs, and labeling translations for FDA, EMA, NMPA submissions. Structured formatting and terminology that regulatory reviewers expect.
Medical Device IFUs
Instructions for Use translated per ISO 14971 risk management standards. We ensure safety warnings, contraindications, and usage steps are unambiguous in every language.
Patient-Facing Materials
PROs, patient education, consent forms, and recruitment materials — written at appropriate literacy levels with cultural sensitivity for diverse patient populations.
Back-Translation & Review
Mandatory back-translation and reconciliation for safety-critical content. Three-step QA: translate → back-translate → reconcile, ensuring zero deviation from source intent.
Post-Market Surveillance
PSURs, PBRERs, adverse event reports, and safety update reports — translated rapidly for pharmacovigilance teams operating across time zones.
Regulatory-Grade Translations
From clinical trials to patient materials — we deliver translations that meet FDA, EMA, and NMPA standards. Get a detailed quote within 2 hours.
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