Regulatory translation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and in vitro diagnostics products. Many countries around the world, including Japan and the United States, require that approval dossiers for new products be submitted in local languages for the regulatory bodies to read and analyze. Similarly, any documentation associated with follow-up changes to approved products or reporting of field issues must be translated for countries that require it.[1]
Aside from linguistic skills, regulatory translation requires specific training and subject matter knowledge in order to translate medical and regulatory content. This is because of the highly technical, sensitive and regulated nature of medical texts as well as the strict adherence to terminology required for some countries. Regulatory translation also requires specific knowledge of the document templates required for different countries' dossier formats. Because approval dossiers are often composed of a variety of different document types, such as CAD drawings, spreadsheets, scanned patient signatures as well as word processed expository sections, the translation process can be more difficult than other types of medical translation.
^Regulations for Medical Devices and the Role of Guidance Documents in Europe [1]
and 24 Related for: Regulatory translation information
Regulatorytranslation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and in vitro...
require translation for local clinicians, patients, and regulatory representatives. Regulatory approval submissions typically must be translated. In addition...
automate translation or to mechanically aid the human translator. More recently, the rise of the Internet has fostered a world-wide market for translation services...
the level of protein biosynthesis (translation), RNA cleavage, RNA splicing, or transcriptional termination. Regulatory sequences are frequently associated...
language translation, including cryptanalysis, frequency analysis, and probability and statistics, which are used in modern machine translation. The idea...
pre-mRNAs to produce mature mRNA ready for translation into protein. Eukaryotic genes typically have more regulatory elements to control gene expression compared...
how to translate), to the point that discussions of translation that were not prescriptive were generally not considered to be about translation at all...
Literal translation, direct translation, or word-for-word translation is a translation of a text done by translating each word separately without looking...
Fan translation (or user-generated translation) refers to the unofficial translation of various forms of written or multimedia products made by fans (fan...
Eukaryotic translation is the biological process by which messenger RNA is translated into proteins in eukaryotes. It consists of four phases: initiation...
RNA (mRNA) that immediately follows the translation termination codon. The 3′-UTR often contains regulatory regions that post-transcriptionally influence...
English translations Bible translations into English Other languages Bible translations by language Difficulties Gender in Bible translationTranslation#Fidelity...
A gene (or genetic) regulatory network (GRN) is a collection of molecular regulators that interact with each other and with other substances in the cell...
Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and...
Muslim to present a translation of the Qur'an in English. The English Translation of the Holy Qur'an with Commentary (1917), translated by Maulana Muhammad...
Google Neural Machine Translation (GNMT) was a neural machine translation (NMT) system developed by Google and introduced in November 2016 that used an...
translational initiation can occur. However, this is not the only regulatory step of translation that involves the 5′ UTR. RNA-binding proteins sometimes serve...
any linguistic rules of translation. The first translation of the Qur'an was performed by Salman the Persian, who translated Surah al-Fatiha into the...
documentation". Translation is typically the most time-consuming component of language localization. This may involve: For film, video, and audio, translation of spoken...
had commissioned the preparation of a Kashmiri translation of the Quran. An incomplete Berber translation may have been promulgated by the Barghawata King...
In the field of translation, a translation unit is a segment of a text which the translator treats as a single cognitive unit for the purposes of establishing...
regulator, or regulatory gene is a gene involved in controlling the expression of one or more other genes. Regulatory sequences, which encode regulatory genes...
A regulatory enzyme is an enzyme in a biochemical pathway which, through its responses to the presence of certain other biomolecules, regulates the pathway...
translations into Native American languages Coptic: Coptic versions of the Bible Cornish: Bible translations into Cornish Corsican: The translation of...
Global Information