Global Medical Regulatory Documentation Review and Communication Support
Soojin Bae Regulatory Services helps life sciences companies communicate complex medical and regulatory information clearly across borders.
Founded by a South Korean MD educated in the United States and Germany, we support pharmaceutical, biotech, and MedTech teams in preparing, reviewing, and translating documentation and regulatory communications for global markets. By combining medical expertise with international experience, we ensure that critical materials are scientifically precise, regulator-ready, and aligned with authority expectations.
Our mission is to help companies move confidently between languages, regulatory systems, and global markets.
We don't generalize; we specialize.
Our Services
We offer specialized support across four core areas:
- Korean – English Regulatory and Medical Translation
- Senior Escalation Review for High-Risk Regulatory Documentation
- Global Documentation & Regulatory Communication Support
- Localized Korean MFDS Documentation & Communication Support
Service 1: Korean – English Regulatory and Medical Translation
MD-led regulator-ready Korean – English translation across the life sciences pipeline using our proprietary in-house CAT tool for high-fidelity document reproduction.
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.
Service 2: Senior Escalation Review for High-Risk Regulatory Documentation
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.
Service 3: Global Documentation & Regulatory Communication Support
Strategic documentation and regulatory communication support for Korean pharmaceutical, biotech, and MedTech organizations expanding into the European Union, North America, and the United Kingdom.
Refinement of briefing books, slide decks, and supporting materials for interactions with authorities including the U.S. FDA, EMA, MHRA, and Health Canada.
Real-time language and documentation support during regulatory meetings, teleconferences, and sponsor–authority discussions.
Preparation of meeting summaries, clarification responses, and action documentation to ensure alignment across international teams.
Senior-level review of regulatory and clinical materials prior to submission to ensure clarity, consistency, and alignment with authority expectations.
Facilitating clear communication between Korean sponsors and Western regulatory counterparts to minimize misunderstandings and streamline review processes.
Service 4: Localized Korean MFDS Documentation & Communication Support
Specialized documentation and regulatory communication support for foreign sponsors and manufacturers preparing submissions to South Korea’s Ministry of Food and Drug Safety (MFDS).
Preparation and refinement of Korean-language regulatory documents aligned with MFDS submission standards.
Adaptation of global regulatory materials to ensure alignment with Korean regulatory expectations while maintaining scientific integrity.
Language and documentation support during regulatory meetings and cross-border sponsor discussions.
Bridging differences in regulatory communication style, documentation structure, and procedural expectations between overseas sponsors and Korean authorities.
Final review to ensure clarity, consistency, and regulatory defensibility prior to MFDS interaction.
About Us
Our Mission
To safeguard scientific integrity and regulatory clarity across global life sciences documentation and communication. We support pharmaceutical, biotech, and MedTech organizations in preparing, reviewing, translating, and validating regulator-facing materials. By combining medical expertise with cross-border regulatory familiarity, we help companies navigate complex submission environments with precision and confidence.
Why Choose Us
Regulatory documentation leaves no margin for error. Whether preparing submissions, responding to authority queries, validating AI-assisted materials, or facilitating cross-border communication, accuracy and clarity are critical at every stage.
Soojin Bae Regulatory Services is founded and led by an MD with deep subject-matter expertise and multilingual fluency in Korean, English, and German. With experience aligned to U.S., EU, UK, and Korean regulatory systems, we provide senior-level oversight for complex, time-sensitive, and authority-facing documentation.
- Medically grounded – Founded by an MD with clinical and regulatory expertise.
- Personalized service – Speak to us directly in Korean, English or German at a clinical level.
- Global regulatory insight – Experience aligned with FDA, EMA, MHRA, MDR/CE marking, and MFDS frameworks.
- High-stakes validation – Skilled in reviewing complex, time-critical, and regulator-facing documentation, including AI-assisted materials.
- Tailored support – designed around your specific project objectives and regulatory requirements.
Founder Story
Soojin Bae, MD
I was born in South Korea, educated in an American school system, and later completed my medical degree at Hannover Medical School in Germany. Moving between cultures and languages from an early age shaped the way I understand communication — particularly in fields where precision is not optional.
During my medical training and subsequent work in clinical and regulatory documentation, I saw how often scientific meaning can shift subtly across languages and regulatory systems. In global life sciences, these nuances matter. They affect clarity, credibility, and ultimately regulatory outcomes.
Soojin Bae Regulatory Services was founded to bridge that gap.
Today, I support pharmaceutical companies, CROs, and biotech teams with senior-level review, translation, and validation of clinical and regulatory documentation across EMA, FDA, MHRA, and MFDS frameworks. My work focuses on ensuring that complex medical information remains scientifically accurate, terminologically consistent, and regulator-ready — whether moving from Korea to Europe and North America, or vice versa.
At its core, this company exists for one reason: to help life sciences organizations communicate across borders without losing precision.
We don’t generalize. We specialize.
Industry Experience
With over six years supporting pharmaceutical, biotech, and MedTech organizations, Soojin Bae Regulatory Services Ltd. provides senior-level review, quality control, and regulatory communication support for documents submitted to global regulatory authorities.
Our experience spans global sponsors, CROs, and Korean life sciences companies pursuing market access in Europe, North America, and South Korea, including supporting leading CROs such as Medpace, ICON, IQVIA, Fortrea, and Syneos Health, as well as major pharmaceutical companies including AstraZeneca, Bayer, Roche, and Otsuka.
Regulatory Documentation
Extensive experience translating and writing documents required for regulatory approval, ensuring compliance, clarity, and scientific precision across international frameworks including FDA, EMA, MHRA, MFDS, and MDR/CE marking. Key document types include:
- Clinical Study Reports (CSR)
- IND, CTA, and CTD modules
- Product dossiers and medical device documentation
Pharmacovigilance & Safety Documentation
Accurate documentation to ensure patient safety and regulatory compliance:
- Adverse Event Reports (AER) / Individual Case Safety Reports (ICSR)
- Serious adverse event (SAE) narratives
- Safety update reports and regulatory follow-ups
Clinical Trial Documentation
Supporting smooth trial conduct, site operations, and participant engagement:
- Study protocols and Investigator’s Brochures (IB)
- Case Report Forms (CRF)
- Study manuals and trial-related guidelines
High-Stakes Review & AI-Integrated Validation
Specialized expertise in high-risk, regulator-facing documentation and AI-assisted content. In many engagements, we have 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, including:
- Senior-level review and quality control of critical documents
- Independent validation of AI-generated regulatory and clinical content
- Resolution of complex scientific, medical, and regulatory interpretation issues
- Final escalation support to ensure accuracy, consistency, and regulatory defensibility
Regulatory Communication & Cross-Border Support
Assisting companies in interactions with regulatory authorities, including:
- Pre-meeting document refinement and briefing materials
- Live language and documentation support for teleconferences or meetings
- Post-meeting debriefs and cross-border coordination
- Alignment of global documentation with authority expectations
FAQ
Q: Which languages do you operate in?
Q: What turnaround options do you provide?
Q: Which time zone do you operate in, and what are your core hours?
Q: Do you offer an initial consultation?
Q: Do you offer a trial project?
Q: Can you sign our NDA or DPA? How do you handle confidentiality and security?
Q: Are you familiar with ICH-GCP and regional regulatory conventions (MFDS, FDA, EMA, MHRA)?
Q: We already work with a primary LSP. Where do you fit within that model?
Q: How is pricing structured for Regulatory Medical Translation (Service 1) and Senior Escalation Review (Service 2)?
Q: How is pricing structured for Global Documentation (Service 3) & Regulatory Communication Support (Service 4)?
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