Organizational
Service Capability Matrix for Medical and Specialized Domain Teams
| Team Name | Core Service Scenarios | Specialized Service Areas | Applicable Regulatory Agencies / Standards | Delivery Standards |
|---|---|---|---|---|
| New Drug Registration Translation Group | Full-module eCTD dossiers; DMF/ASMF files; NDA/BLA/IND submission dossiers; multi-regional registration adaptation; New Drug Launch documents; health supplement and veterinary medicine registration dossiers | New Drug Launch, health supplements and veterinary medicine, TCM internationalization, biotechnology (biologics / gene therapy registration) | NMPA (China), FDA (US), EMA (EU), PMDA (Japan), Health Canada, TGA (Australia), Ministry of Agriculture and Rural Affairs (veterinary medicine), FDA CVM (veterinary medicine), EMEA Committee for Veterinary Medicinal Products | 100% terminology consistency; zero deviation in formatting compliance; precise adaptation of regulatory expressions; 99% expedited delivery rate; 98% registration pass rate |
| Clinical Trials Translation Group | Clinical trial protocols / CRFs / CSRs; Investigator's Brochures; Informed Consent Forms; AE/SSR reports; statistical analysis documents; health supplement and veterinary medicine clinical trial dossiers | Clinical Trials, biotechnology (clinical research), in vitro diagnostics (clinical trials) | ICH GCP, NMPA GCP, FDA GCP, EMA GCP, PMDA GCP, VICH guidelines for veterinary clinical trials, IVDR (in vitro diagnostic clinical trials) | Zero errors in clinical data; coherent logic without ambiguity; ethical compliance met; 100% adaptation to GCP standards; clear data traceability |
| Pharmaceutical Patent Translation Group | Compound / formulation / preparation method patents; medical device patents; biologics patents; veterinary medicine patents; medical aesthetics device patents; in vitro diagnostic patents | Biotechnology (patents), Medical Devices (patents), cosmetics (medical aesthetics patents), in vitro diagnostics (patents) | CNIPA (China), USPTO (US), EPO (EU), JPO (Japan), KIPO (South Korea), Ministry of Agriculture and Rural Affairs Patent Standards | Zero deviation in technical details; rigorous legal expression; clear claim boundaries; 100% confidentiality compliance rate; 85% patent grant support rate |
| Medical Devices Translation Group | Technical manuals; clinical evaluation reports; registration dossiers; operation / maintenance manuals; GMP documents; in vitro diagnostic reagent documents; digital healthcare equipment materials; medical aesthetics device documents | Medical Devices, in vitro diagnostics, Digital Healthcare, cosmetics (medical aesthetics devices) | NMPA Medical Devices Registration Standards, FDA 21 CFR, EMA MDR/IVDR, PMDA Medical Devices Guidelines, ISO 13485, Digital Healthcare Privacy Standards (HIPAA/GDPR) | 100% accuracy of technical parameters; 100% restoration of chart formats; 99% registration compliance pass rate; consistent multilingual adaptation; privacy compliance met |
| Academic Translation and Dissemination Group | SCI/SSCI papers; grant applications; project reports; academic monographs; international conference presentations / PPTs; Academic Training courseware | Academic Training, biotechnology (academic dissemination), TCM internationalization (academic promotion) | Top medical journal standards (JCO, Nature Reviews, etc.), scientific research grant application requirements, international academic conference standards | Academic rigor met; journal style adaptation; 85%+ first-round submission success rate; highly readable training courseware; zero deviation in professional terminology |
| TCM/Botanical Drug Translation Group | TCM registration dossiers; FDA botanical drug submission documents; TCM package inserts; manufacturing process documents; traditional terminology adaptation; TCM international promotion materials | TCM Internationalization, biotechnology (plant extracts) | NMPA TCM Registration Standards, FDA Botanical Drug Guidelines, EMA Botanical Drug Requirements, WHO Traditional Medicine Standards | Precise conversion of traditional terminology; modern regulatory adaptation; preservation of cultural characteristics; 98% submission pass rate; strong adaptability for international promotion |
| Multilingual Localization Translation Group | Multilingual registration dossiers; localization of package inserts; marketing manuals; patient education materials; employee training documents; cosmetics product copy; health supplement and veterinary medicine promotional materials | Multilingual Localization, cosmetics (product copy), health supplements and veterinary medicine (marketing materials), Academic Training (multilingual courseware) | Regulatory standards across 30+ global regions; cultural adaptation requirements of target markets; cosmetics labeling standards (CPR / China GB); veterinary medicine labeling standards | Authentic and natural language; highly tailored cultural adaptation; unified regulatory terminology; coverage of 30+ languages; 99% on-time delivery rate; compliant and unambiguous copy |
| Compliance and Technical Review Group | Technical accuracy review of translations; regulatory compliance review; terminology consistency validation; resolution of technical issues involving emerging technologies; language validation; compliance support (interpretation of regulatory feedback / compliance consulting) | Compliance Support, language validation, full-scope compliance review | Latest standards of major global regulatory agencies (updated in real-time); ISO 17100 translation quality standards; language validation industry standards | Review error rate <0.5%; zero omission of compliance issues; unified terminology calibration; dispute resolution response within 24 hours; 100% language validation pass rate |
| Cosmetics Translation Task Force | Cosmetics registration dossiers; medical aesthetics device technical documents; product instructions; translation of ingredient lists; marketing copy; safety evaluation reports | Cosmetics, Medical Devices (medical aesthetics) | NMPA Cosmetics Regulatory Standards, EU Cosmetics Regulation, FDA Cosmetics Labeling Requirements, EMA MDR standards for medical aesthetics devices | Precise ingredient terminology; label compliance met; no exaggeration in promotional copy; professional technical documents; effective multilingual localization adaptation |
| Digital Healthcare Translation Task Force | Digital healthcare platform documents; remote diagnostic system materials; health management app copy; medical big data reports; AI medical algorithm descriptions | Digital Healthcare, biotechnology (AI healthcare) | HIPAA (Privacy), GDPR (Data Protection), NMPA Digital Healthcare Registration Standards, FDA Software as a Medical Device (SaMD) Requirements | Clear technical logic; privacy compliance met; easy-to-understand user copy; accurate data terminology; consistent cross-platform adaptation |
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