Client
A leading pharmaceutical company operating in the Asian market with R&D activities spread across Japan, China, and Korea. The company specializes in multiple therapeutic areas, and our collaboration focused on documentation for a series of neurovascular products.
Problem
The client faced significant challenges in preparing documentation for a multilingual FDA submission. Their working documentation was multilingual, containing Japanese, Korean, Chinese, and English content. To meet FDA requirements, they needed all documents translated into English while ensuring structural compliance, terminology consistency, and adherence to current FDA guidelines. Additionally, the client aimed to simplify and accelerate the regulatory submission process, but lacked the internal resources and expertise to handle such a complex multilingual and regulatory task efficiently.
Solution
We provided a comprehensive solution combining high-quality translation services, regulatory consulting, and advanced technology tools. Our team of subject matter experts (SMEs) ensured that all terminology used was consistent with the latest FDA requirements and regulatory standards. We didn’t stop at translation—we also verified document structure and formatting compliance with FDA expectations.
To guarantee accuracy and efficiency, we used specialized tools for automated compliance checks. These tools scanned documentation for regulatory alignment, structural integrity, and terminology accuracy, reducing manual effort and minimizing errors. The combination of human expertise and technology allowed us to deliver precise, submission-ready documentation.
Result
In 2024, we successfully processed nearly complete documentation packages for three neurovascular pharmaceutical products for this client. The quality of work, speed of execution, and regulatory precision not only resolved their documentation challenges but also helped them simplify and accelerate their FDA submission process. The client expressed full satisfaction with our services and tools and has confirmed their intention to continue collaboration on future projects.
Our case proves that with the right partner, the complexity and pain of multilingual FDA documentation preparation can be transformed into a smooth, efficient process, supported by regulatory expertise, cutting-edge technology, and reliable consulting.
