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Pharmaceuticals

Virtually all modern pharmaceutical products require translation services. The cost of bringing new medications to market is often so high that only the ability to secure exclusive legal rights and regulatory approval in desired treatment protocols across many countries justifies the expense beyond initial research. That requires translation at many, if not all, stages of drug development.

A rudimentary form of pharmaceutical medicine predates recorded history. The earliest surviving texts include medical tracts, indicating the existence of medical prescriptions. Sumerian cuneiform tablets dating from more than 4,000 years ago¹ and an Egyptian papyrus, the Kahun Gynecological Papyrus, dated at about 1800 BCE,² are among the oldest extant texts containing prescriptions for topical or oral medications.

Proof of translation of early prescription remedies from Egyptian hieroglyphs to ancient Greek dates back at least to Homer's Odyssey, circa 880 BCE, wherein he observed, "In Egypt, the men are more skilled in medicine than any of human kind."

Pharmaceutical translation is a sophisticated process with exacting levels of language quality control and requiring multilanguage output for successive stages of drug development. Volumes of content vary widely from single brief patents, correspondence, and twenty-patient Phase I clinical trials to twenty-language patent applications, regulatory submissions, inch-thick licensing agreements, extensive thirty-plus-language Phase III clinical trials, thousands of pages of process, MSDS, and manufacturing documentation, precise multilingual patient information, medical packaging and insert materials, and finally online and print marketing and informational materials authored and translated for both medical professionals and consumer audiences.

McElroy has established processes in place specifically designed to handle variable volumes of pharmaceutical content at all stages of development, based on volume pricing. Most important, McElroy has experience in satisfying the translation quality requirements of U.S. IRBs, the FDA, NIH, EUCD, and other regulatory agencies, plus all major international patent offices. With medical and pharmaceutical expertise in more than 85 languages, McElroy is able to provide highly technical documentation including CRFs, ICFs, PROs, training documentation, clinical study protocols, packaging and labeling, and brochures for Europe and BRIC (Brazil, Russia, India, China) regions as well as South Korea, Japan, and South Africa.

1 Medicine in Ancient Mesopotamia, Indiana University.

2 Manuscript for the health of mother and child, translation by Stephen Quirke.

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