Streamlining Multilingual Regulatory Workflows in Life Sciences
Seprotec implemented a scalable multilingual workflow for a global medical device manufacturer, combining specialized Life Sciences expertise, structured quality processes, post-editing and multilingual DTP to deliver regulatory-ready documentation in more than 30 languages.
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Objective
Implement a scalable and regulatory-compliant translation workflow for IFUs, complaint documentation and quality documents, ensuring fast turnaround times, cost efficiency and full compliance with EMA, FDA and PMDA requirements.
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Challenge
Managing multilingual documentation involved complex operational and compliance requirements, including updates and new translations into more than 30 languages, complex DTP formats such as FrameMaker and InDesign, strict file naming and reporting requirements, signed release documentation and the integration of local market feedback into translation memories.
The workflow also needed to ensure the security of sensitive regulatory and complaint data. -
Implementation
Seprotec established a dedicated Life Sciences project team to coordinate linguists, reviewers, DTP specialists and validation stakeholders.
Translations follow the four-eyes principle, followed by QA and final layout validation.
Selected content uses a standardized machine translation post-editing workflow.
Local market feedback is incorporated into translation memories and terminology databases, while specialized DTP teams manage formatting, barcode integration, language-specific layouts and final compliance checks. -
Result
The workflow enables reliable simultaneous delivery into more than 30 languages, supporting regulatory compliance and submission readiness.
Optimized processes provide faster turnaround times, while improved use of translation memories generates long-term cost savings.