Global Regulatory StrategyTranslation & Consulting

We cover 40+ regulatory markets for simultaneous submission programs, including FDA (US), EMA (EU), PMDA (Japan), Health Canada, TGA (Australia), ANVISA (Brazil), NMPA (China), MFDS (South Korea), Swissmedic (Switzerland), SAHPRA (South Africa), Gulf Health Council (GCC), WHO Prequalification, and ASEAN member states. We have dedicated regional teams for each major market.

Consistency is maintained through centralized Translation Memory management and global regulatory terminology databases. Once a sentence is translated and approved in the master dossier, it is reused consistently across all subsequent documents and all target markets. Our global program manager conducts cross-market consistency reviews at key milestones to verify that benefit-risk messaging and scientific content are consistent across all markets.

Yes. We translate Health Technology Assessment dossiers for NICE (UK), HAS (France), G-BA (Germany), CADTH (Canada), PBAC (Australia), and other national HTA bodies. Our HTA translation specialists understand the specific evidence requirements and submission formats of each HTA body, including NICE Single Technology Appraisal format, HAS Dossier de demande d'inscription, and G-BA Dossier zur Nutzenbewertung.

Yes. We provide translation services for WHO Prequalification Programme submissions for essential medicines, vaccines, and diagnostics. Our WHO PQ translation specialists understand the specific dossier requirements and quality standards of the WHO Prequalification Programme, which is critical for market access in low- and middle-income countries.

We have a dedicated ANVISA translation team with linguists who hold advanced degrees in pharmaceutical sciences and regulatory affairs and have direct experience with ANVISA submission requirements. We translate pharmaceutical registration dossiers under ANVISA RDC 204/2017 (new drugs) and RDC 73/2016 (biological products), including the specific Portuguese-language formatting and content requirements of ANVISA.

Yes. We have a dedicated NMPA translation team for China regulatory submissions. We translate pharmaceutical registration dossiers under NMPA technical guidelines, including clinical data packages, manufacturing documentation, and Chinese-language labeling. We are familiar with the specific requirements of NMPA's Center for Drug Evaluation (CDE) for innovative drugs, including the requirements for clinical data generated in Chinese patients.

For a 10-market simultaneous submission program, we appoint a dedicated global program manager who coordinates all regional translation teams. We establish a master Translation Memory and global terminology database before translation begins. Regional teams translate in parallel, with weekly cross-market consistency reviews. We deliver all market submissions simultaneously, with Certificates of Translation and audit trails for each market. Our program management infrastructure is designed to handle the complexity of large multi-market programs without compromising quality or timelines.

While the ICH CTD format provides a common structure for multi-market submissions, regulatory terminology varies significantly between markets. For example, the FDA uses 'Investigational New Drug Application' while the EMA uses 'Clinical Trial Application' and PMDA uses 'Clinical Trial Notification.' Our global regulatory terminology database documents these market-specific variations, ensuring that each translated submission uses the correct terminology for the target authority.