Hansem Global localizes regulated content such as IFUs, labeling, packaging, and regulatory submissions for the medical device, pharmaceutical, and biotech industries, so manufacturers can meet each market's language and labeling requirements.
Full ISPOR-guideline validation, including back translation and cognitive debriefing, for eCOA and patient-reported outcomes. This is the part of life science translation AI can't automate.
IFUs, labeling, and submissions translated with controlled terminology, aligned to 21 CFR Part 801, ISO 20417, and ISO 15223-1 — audit-ready.
AI-assisted speed, verified through an ISO 17100 process, LQA review, and our in-house Hansem QA solution. Confidential by default.
Patient-facing and regulated content, such as eCOA instruments, IFUs, and consent forms, must be understood exactly as the source intends. Linguistic validation, including back translation and cognitive debriefing, confirms that the meaning itself survives the language change.
Controlled terminology and standard-aligned translation cut the labeling and instruction errors that trigger submission queries, market holds, or recalls.
IFUs, labeling and packaging, regulatory submissions, eCOA and clinical questionnaires, patient-reported outcome instruments, and patient-facing materials.
Our eCOA services cover the full instrument lifecycle. We translate and culturally adapt eCOA content so each item keeps its intended meaning across languages and patient populations, then manage migration from paper to the electronic platform with screenshot review to get the on-screen presentation right early. Translated instruments go through structured quality checks for accuracy, regulatory appropriateness, and cultural fit, with support aligned to trial phases and regulatory requirements.
Full-cycle eCOA localization that keeps patient responses accurate and comparable across languages.
Our linguistic validation follows the ISPOR-guideline process. We translate and validate patient-reported outcomes, clinical trial protocols, and consent forms, then run cognitive debriefing: interviews with target-language speakers to confirm they understand the content as intended. We harmonize across languages so meaning and assessment stay consistent, and document the full process, including the methodologies used and the rationale behind each linguistic choice.
ISPOR-guideline linguistic validation that confirms meaning, not just words, survives translation.
Hansem Global translates pharmaceutical documents across the full regulatory lifecycle. Our scope includes Common Technical Documents (CTD/eCTD), Drug Master Files, toxicology reports, Chemistry, Manufacturing and Controls (CMC), animal study reports, pharmacovigilance (PV) documents, and regulatory submissions to the FDA, EMA, and NMPA. We also translate Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOP), Master Batch Records, patents, packaging labels and inserts, and legal and regulatory documents, with controlled terminology that keeps content consistent and submission-ready across global markets.
Translation capabilities across the pharmaceutical regulatory lifecycle — from CTD/eCTD to GMP and labeling.
Hansem Global provides specialized translation for a wide range of clinical documents used across global trials. Our scope covers clinical trial documentation, Informed Consent Forms (ICFs), Clinical Outcome Assessments (COAs), clinical trial agreements, Clinical Study Reports (CSRs), Investigator’s Brochures, patient recruitment materials, and adverse event reporting, including Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and Case Report Forms (CRFs). We also translate Electronic Health Records (EHRs), Development Safety Update Reports (DSURs), and Patient Information Sheets, keeping content accurate and accessible for sponsors, sites, and patients.
Specialized translation for clinical trial documents, from ICFs and COAs to CSRs and safety reports.
Hansem Global provides translation for life science research and medical device documentation used in global distribution and regulatory submission. Our scope includes research findings, clinical study reports, and clinical documents, along with medical journals and articles, supporting documentation for CE submissions, ISO documents, and regulatory submission dossiers. We also translate software and hardware manuals, Instructions for Use (IFUs), packaging inserts, sensitivity and biocompatibility reports, product brochures, quality system documents, technical documents, and validation reports.
Translation for life science research and medical device documentation, from IFUs to regulatory dossiers.
Every Hansem translation follows the ISO 17100 two-linguist (four-eyes) review process and is delivered under ISO 27001-certified data security. Backed by ISO 9001, 17100, 18587, and 27001 certifications, Hansem gives regulated industries a translation partner they can audit and trust.
Case studies, guides, and articles related to this service.
Entering the U.S. Medical Device Market: IFU and FDA Compliance in One Step
Why Choosing Professional Medical Document Translation Services is Crucial for Healthcare Providers?
Breaking Barriers: How Clinical Trial Translation Drives Global Medical Advancements
How to Market a Medical Device in the U.S.—What You Need to Know
