1. Regulatory Inspection & Client Audit Translation

· On-site interpretation and real-time document translation for FDA/EMA/NMPA inspections

· Seamless bilingual communication support for remote audits

2. Regulatory & Compliance Documentation Translation

· Specialized translation of pharmaceutical submissions (IND/NDA/ANDA/DMF/CEP/ASMF), GMP documents, SOPs, etc.

· Industry-compliant terminology standardization

3. Conference & Training Interpretation Services

· Simultaneous interpretation for regulatory meetings (Pre-IND, PAI inspections)

· Terminology consistency management for industry seminars and GMP trainings

Customized Translation Solutions

1. Dedicated Industry Team

· QA/RA specialists + translators with 10+ years of experience, utilizing a 3,000+ core terminology database

2. Triple-Layer Quality Assurance

· Human translation → Bilingual expert review → QA/RA compliance verification

3. End-to-End Solutions

· Comprehensive services covering both written documents and verbal communication, tailored to diverse scenarios

1. Pharmaceutical/Food manufacturers undergoing FDA/EDQM/NMPA inspections

2. Companies requiring international product registration (drugs, food, medical devices, cosmetics, tobacco)

3. CROs/CDMOs outsourcing regulatory documentation services