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The Challenges of Translating Medical Documents

March 19, 2015

Medical translation is a unique field in which foreign language expertise is not the only requirement for preparing a professional translation.  The translator need to not only be a native speaker of the language the document is being translated into, but must also have subject matter expertise in the specific medical field. Between shorthand and industry specific jargon, the medical industry practically has a language of its own. Translation companies that are not specialized often rely on translators that do not have a firm understanding of the document that needs to be translated. If a medical translator does not have an academic and experiential background in life sciences, then they are the wrong person for the job.

Whether you are Fortune 500 pharmaceutical or medical device company, or a biotech startups or CRO, your market and products will differ, but the paperwork and other hurdles on the path to regulatory approval are similar. Translating dossiers, exhibits, and reams of other documents is an everyday part of the process. Additionally there are a multitude of procedural issues that come into play with the medical field. Standardization (such as for CRF’s or in labeling), ensuring regulatory compliance for all documents, and providing translations in submission-ready templates and formats are common practice and just the tip of the iceberg for the medical field. To the dismay of many applicants, applications have been rejected by regulatory bodies like the FDA because of inconsistencies and errors in their CMC documentation.

Morningside ensures that all of our medical translators are medically and scientifically qualified  with industry experience in the specific medical field at issue.. We follow the highest standards of translation quality, and our quality management system is officially ISO 9001:2008 certified. Our medical translators have extensive experience translating clinical research, regulatory documents, drug development, and medical device documentation. When it comes to medical translation, don’t risk compromising on quality. Make sure you work with a translation company that offers certified quality for the life sciences industry.