Medical Translation - Regulatory
As a long-term solution, ForeignExchange proposed a new process for dossier development. Our client would write an English dossier, in the correct PMDA structure, with input on requirements from the Japanese affiliate. Then the dossier would be translated into Japanese and reviewed by the Japan office for language accuracy and adherence to appropriate PMDA standards. These reviews would be implemented into a final Japanese version that was then submitted to PMDA and archived at US headquarters.
“ ForeignExchange has not only helped us to stay compliant and viable in what is one of our largest markets but has introduced the side benefit of improving our company teamwork across the world.” - large medical device company
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