Medical Translation

Manpower & Strength

Linguistic competence and great depth of industry-specific expertise are prerequisites for medical translation.
All of Hi-touch's Project Leaders (PLs) and Project Managers (PMs) majored in medicine, pharmacy, and science and engineering, and have extensive knowledge of medical documents, with document analysis and research skills beyond translation.
Comprised of doctors, pharmacists, nurses, and linguists with backgrounds in science and engineering, our medical translation team has a great wealth of expertise and experience in pharmaceutical and medical documents.

Languages

The quality of translation plays a critical role in ensuring that drugs and medical devices are approved by domestic and foreign regulatory authorities during the approval process.
In addition to English, accounting for the absolute majority of medical translation languages, our multilingual staffing provides services for regulatory authorities in Korea, Japan, China, the United States, and the European Union to facilitate the domestic and overseas approval of drugs and medical devices.

Scope of Documents

Hi-touch provides translation services on almost all types of medical and pharmaceutical documents.

Clinical Studies

  • Common technical document (CTD)
  • Synopsis & protocol
  • Case report form (CRF)
  • Subject information sheet
  • Informed consent form (ICF)
  • Investigator's brochure (IB)
  • Interim report / clinical study report
  • IRB approvel letter / notification letter

Other IND & approval-related documents

  • Drug manufacturing materials (GMP, manufacturing process, batch production record, etc.)
  • Non-/pre-clinical studies / animal experiments
  • Post-marketing surveillance (PMS)
  • Contract research agreements
  • Drug safety (PSUR, DSUR, etc.)
  • Risk/benefit materials (PBRER etc.)

Regulatory materials

  • Label
  • SmPC, package leaflet, IFU, etc.
  • Risk management plan (RMP)
  • Bioequivalence studies
  • Safety/efficacy/clinical performance studies
  • Review materials for breakthrough/in vitro diagnostic medical devices
  • Investigational New Drug Application (IND), New Drug Application
  • Marketing/manufacturing authorization application and report
  • Evidence request / response letter

Other medical materials

  • Standard operating procedure (SOP)
  • Food and Drug Administration (FDA) materials
  • Ministry of Food and Drug Safety (MFDS) materials
  • MFDS guidelines
  • GCP/GVP materials
  • Laboratory test materials
  • Lecture videos / scripts
  • Journals / papers
  • Laws, rules, regulations, enforcement regulations, and policy materials

Track Record

Count of Medical Translations

business years23 clients200+ linguists200+ projects50,000+

World leading organizations with Hi-touch Translation

Domestic and overseas pacesetting pharmaceutical and healthcare companies, CROs, and medical institutions trust the Hi-touch's quality of translation services.

Counts of clinical and medical documents translated in recent 5 years (more than 12,000 projects)

  • 2,500 + projects from Jeil Pharmaceutical, Genetox, Ferring Korea, etc. in 2003
  • 2,300 + projects from National Institute of Environmental Research, Abbott Korea, Ildong Pharmaceutical, Straumann, etc. in 2022
  • 2,300 + projects from National Cancer Center, Sanofi, Korea University Ansan Hospital, Biotronic, etc. in 2021
  • 2,200 + projects from Merck, Seoul National University College of Medicine, Severance Hospital, SD Biosensor, etc. in 2020
  • 2,000 + projects from Boehringer Ingelheim Korea, National Institute of Medical Device Safety Information, Yonsei University, etc. in 2019

Quality Control

QA/QC

We guarantee translation services of high caliber, based on quality assurance (QA) and quality control (QC) processes under ISO 9001 and ISO 17100.
QA: A proactive process to ensure consistent quality, including guidelines for terminology, style, etc. at the beginning of a project
QC: A full inspection process, including feedback and correction after the translation is finished
We meticulously analyze and revise any translated documents and are responsive to client requests.
We also provide verification/validation service upon a client’s request.

Adherence to global standard terms/
guidelines

As a basis for our customer-specific medical terminology database, we apply the most up-to-date references, including the most updated guidelines and medical terminology from domestic and overseas regulatory authorities (e.g., the latest version of MedDRA, MFDS guidelines, etc.), tailored to client needs. These international standards-compliant references are the backbone of our QA/QC process.

Certified Translations

As a language service provider, we offer certificates of translation, including ISO9001 and ISO17100 certificates, translators' CVs, and a signed statement that translation quality is guaranteed in compliance with our quality assurance/quality control system, on request.

CAT Tool

With advanced software and IT tools, the translation process is streamlined, conducing to scalable and verifiable results in terms of consistency and standardized terminology. Using CAT Tools, tailored glossaries and Translation Memories(TM) are managed, ensuring consistency across multiple translation projects per client and guaranteeing bespoke translation service.