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.Localized IFUs, labeling, packaging, and regulatory submissions for medical device, pharmaceutical, and biotech markets.
Linguistic validation based on established ISPOR good-practice principles, including back translation and cognitive debriefing for eCOA and patient-reported outcomes.
Controlled terminology and standard-aligned workflows for IFUs, labeling, and regulatory documentation, with requirements such as 21 CFR Part 801, ISO 20417, and ISO 15223-1 reflected where applicable.
AI-assisted workflows combined with expert human review, ISO 17100-based quality processes, LQA, and Hansem QA to maintain accuracy, consistency, and confidentiality.
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 established ISPOR good-practice principles. We translate and validate patient-reported outcomes, clinical trial materials, and informed consent forms, with processes such as back translation, harmonization, and cognitive debriefing where required. Cognitive debriefing with target-language speakers helps confirm that patients understand the content as intended. We document the validation process and the rationale behind key linguistic decisions to support consistency across languages and patient populations.
Linguistic validation that confirms meaning and patient understanding across languages.
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 translates medical device and life science research documentation for global distribution, clinical use, and regulatory submission. Our scope includes Instructions for Use (IFUs), user and service manuals, labeling and packaging content, regulatory dossiers, validation reports, quality system documents, biocompatibility and safety reports, clinical study reports, research findings, and scientific publications.
For medical device documentation, we apply controlled terminology and consider relevant regulatory and documentation requirements to maintain consistency across product information, labeling, and technical documentation.
Translation for medical device and research documentation, from IFUs and labeling to regulatory dossiers and scientific content.
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
FDA Medical Device Webinar: IFU and Labeling
