2021-07-21 12:02
The Common Technical Document (CTD) is a set of specifications for a dossier to register medicines. After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada, Australia and Switzerland. Th
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2021-07-21 12:02
Regulatory compliance is the key to acquiring product licenses and the cornerstone to access new markets. The regulatory translation is the translation of documentation on the approval and compliance of medical devices, pharmaceuticals and in vitro d
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2021-06-27 19:58
The pharmaceutical translation is required at many stages, including clinical research, regulatory submission and review, production, and marketing. Accurate pharmaceutical translation services mainly help drug companies grow pharmaceutical sales int
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2021-06-27 19:57
CMC stands for Chemistry, Manufacturing and Controls. The process in which drugs are evaluated with regard to their specific qualifications is called CMC documentation. It defines not only the manufacturing process itself but also the quality control
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2021-06-27 19:57
The SmPC is part of the broader Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. Accurate translation of drug instruction texts, especially thos
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2021-06-27 19:56
United States Prescribing Information (USPI) sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, also known as the drug product label, prescription drug labeling, product insert, package insert, profe
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2021-06-27 19:56
More clinical trials are conducted in multi-countries, such as Asia, Latin America, or Central and Eastern Europe. Even US-based studies recruit the majority of the subjects for clinical studies outside the US. Translation is required at many stages
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2021-06-27 19:56
The Common Technical Document (CTD) is a set of specifications for a dossier to register medicines. After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada, Australia and Switzerland. Th
... дальше

2021-06-27 19:55
Regulatory compliance is the key to acquiring product licenses and the cornerstone to access new markets. The regulatory translation is the translation of documentation on the approval and compliance of medical devices, pharmaceuticals and in vitro d
... дальше