Specialist Korean → English Medical Translation for Clinical & Regulatory Documents
Soojin Bae Medical Translation specializes in regulator-facing Korean → English translation and senior-level escalation for clinical and regulatory documentation. With over six years of experience and 1,200+ completed projects, we have supported global CROs and pharmaceutical companies, including AstraZeneca, Otsuka, Bayer, and Roche.
Every client works directly with an experienced MD translator — ensuring medically accurate translations, faster communication, and tailored support.
We don't generalize; we specialize.
Core Translation Services
Regulator-ready Korean → English translation across the life sciences pipeline.
Protocols, Investigator’s Brochures (IB), and study-related documentation, translated with up-to-date medical expertise to ensure compliance and clarity.
Clinical Study Reports (CSR), IND/CTA/CTD modules, and clinical trial disclosure documents prepared for global regulatory agencies.
Adverse event reports, DSUR, PSUR, narratives, and safety documentation, translated accurately and on time to meet regulatory deadlines.
Medical information, publications, and scientific communications handled with precision and subject-matter expertise.
Informed Consent Forms (ICF) and patient-facing documents translated with clarity, accuracy, and cultural sensitivity.
High-Escalation Regulatory & Medical Language Support
Senior escalation support for high-risk, time-critical, or regulator-facing documentation where precision, regulatory credibility, and medical judgment are essential.
Final sign-off for regulator-facing content to ensure clinical logic, terminology accuracy, and linguistic precision.
Medical validation and correction of AI-generated or vendor translations where accuracy and credibility must be defensible.
Focused revisions following questions, findings, or feedback from MFDS / EMA / MHRA / FDA and other authorities.
Resolution of terminology and consistency issues where wording affects interpretation, safety meaning, or compliance risk.
Alignment of translated content with EU expectations and CTD standards for clarity, internal consistency, and submission readiness.
Engagements are handled directly by an MD-led senior linguist with extensive regulatory exposure. This is not volume translation; it is risk containment and regulatory readiness.
Quality & Compliance
Our workflows follow the principles of ISO 17100. While we are not
yet formally certified, we apply these practices in every project:
dual-review translation and editing, terminology consistency, and
secure document handling. As our team expands, we plan to obtain
full ISO 17100 certification.
High-Fidelity Formatting
Formatting and layout are handled using our proprietary in-house CAT
tools, specifically optimized for regulatory documents. Unlike
standard workflows that convert Korean PDFs into Word with
formatting loss, our process maintains high fidelity to the source
PDF, preserving tables, forms, and images. This minimizes review
burden and reduces compliance risk. Final deliverables are available
in both Word and PDF formats.
About Us
Our Mission
To deliver regulator-ready Korean → English translations that combine medical expertise with technical precision. By uniting the insight of an MD translator with workflows aligned to international standards, we help pharmaceutical companies and CROs submit documentation with confidence, accuracy, and efficiency.
Why Choose Us
Pharmaceutical documentation leaves no margin for error. Yet in most large translation agencies, communication passes through multiple layers of project managers and reviewers, which can slow timelines and dilute subject-matter clarity.
At Soojin Bae Medical Translation, you work directly with the linguist — an MD with extensive experience in clinical and regulatory translation. This streamlined approach ensures medically accurate translations, faster responses, and immediate clarification of technical queries.
- Our linguist is an MD: We understand your subject matter at a clinical level.
- Personalized service: Speak to us directly in Korean or English, without intermediaries.
- Consistency and uniformity: Every project handled by the same translator, ensuring regulator-ready consistency.
- High-fidelity reproduction: Proprietary in-house CAT tool preserves tables, forms, and formatting.
Our Team
Based between Korea and Europe, we combine medical expertise and technical innovation to deliver translations that meet the highest global standards. Our international background sets us apart: with education and professional experience in the U.S. and Europe, we bring a broader perspective than most Korea-based translators.
Soojin Bae, MD — Founder & Lead Translator
Born in South Korea, educated in the U.S. and with a medical degree from Hannover Medical School in Germany, Soojin combines medical training with specialized experience in Korean → English clinical and regulatory translation. She has completed 1,200+ projects supporting major CROs and global pharmaceutical companies, and has clinical research experience at Samsung Medical Center (Department of Pediatric Oncology, Seoul), including co-authorship of a peer-reviewed paper [PubMed link]. She is a native speaker of Korean and English, with additional fluency in German and Romanian.
Daniel Kennedy — Co-Founder & Technical Lead
With a decade of management experience at Blizzard Entertainment in technical documentation and compliance, Daniel, who is English, brings rigorous process design and IT expertise. He developed our proprietary in-house CAT software, purpose-built for life sciences and regulatory translation. His focus is ensuring every deliverable maintains precise formatting, fidelity to the source document, and strict compliance with regulatory standards.
Future Growth
While Soojin translates every project personally, we also employ additional linguists as reviewers and DTP staff as needed, ensuring the capacity to deliver high-quality translations and submission-ready documents on schedule. As demand grows, we plan to expand our dedicated in-house team in Korea, maintaining continuity, speed, and quality without compromising the personal service that defines our approach.
Industry Experience
For over six years, our lead translator has contributed to regulatory submissions and disclosures across a wide range of therapeutic areas. Her translations have supported leading CROs such as Medpace, ICON, IQVIA, Fortrea, Syneos Health, and Worldwide Clinical Trials, as well as major pharmaceutical companies, including AstraZeneca, Bayer, Roche, and Otsuka.
Regulatory Documentation
Extensive experience translating documents required for regulatory approval, ensuring compliance, clarity, and precision for global agencies. Key examples include:
- Clinical Study Reports (CSR)
- IND, CTA, and CTD Modules for FDA, EMA, MHRA, and MFDS
- Product dossiers and medical device documentation
Pharmacovigilance and Safety
Accurate documentation to ensure patient safety and regulatory compliance:
- Adverse Event Reports (AER) / Individual Case Safety Reports (ICSR)
- Serious adverse event (SAE) narratives
- DSUR, PSUR, and Risk Management Plans
Clinical Trial Documentation
Supporting smooth trial conduct, site operations, and participant engagement:
- Protocols and Investigator’s Brochures (IB)
- Case Report Forms (CRF)
- Study-related manuals and guidelines
Patient Engagement Materials
Clear, culturally sensitive translations for patient-facing documents:
- Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
- Patient leaflets and recruitment materials
Medical Affairs & Scientific Communications
Translations for publications, research, and professional communications:
- Academic papers and research manuscripts
- Medical information letters for healthcare professionals
Advanced QA & Regulatory Escalation Experience
In addition to primary translation work, Soojin also has extensive experience providing advanced quality assurance and escalation support for Korean → English clinical and regulatory documentation.
This includes:
- Senior medical and linguistic QA of regulator-facing documents
- Review and correction of translations produced by other linguists or vendors
- Resolution of complex medical, scientific, and regulatory interpretation issues
- Targeted post-submission revisions following authority questions or feedback
- Ensuring terminology, logic, and tone are aligned across multi-document submissions
In many engagements, she has served as the final escalation point when accuracy, consistency, or regulatory credibility was critical — particularly for submissions approaching or undergoing MFDS, EMA, MHRA, or FDA review.
How We Work
- Secure submission → Client uploads documents to our encrypted server.
- Translation by an MD → Specialized medical translator ensures accuracy and compliance.
- DTP & formatting → Proprietary CAT tools maintain document fidelity, preserving tables, forms, and graphics.
- Second edit & QA → Every document reviewed for consistency, clarity, and compliance.
- Final delivery → Submission-quality Word and PDF files, formatted to the highest standards for regulatory review.
Security & Confidentiality
All projects are handled under strict confidentiality agreements and secure data protocols, in compliance with international regulatory standards.
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