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Regulatory Affairs
TransPerfect's experience within highly-regulated industry sectors is second-to-none. Many of our projects take place within the strict frameworks laid down by the world's most prominent regulatory bodies. Our familiarity with the operations of the relevant competent authories has allowed us to develop customized workflows that reduce the lag time often associated with the submission of multilingual new drug applications.
- The Food and Drug Administration (FDA)
- The European Medicines Agency (EMEA)
- Ethics Committees
- Institutional Review Boards
Our ISO 9001:2008-certified quality control procedures also help mitigate risk by reducing the possibility of costly errors and inconsistencies.
All projects pertaining to regulatory affairs are handled by expert linguists with many years' industry experience. Many of our pharmaceutical linguists hold PhDs, Master's Degrees or PharmDs, guaranteeing the highest levels of quality and stringent dedication to fulfilling regulatory requirements. The depth and breadth of our knowledge makes TransPerfect the first choice for a wide range of projects, from the translation of QRD documentation to the localization and regulatory review of drug labeling in strict accordance with MedDRA terminology.
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