Pharmacology Regulatory Documentation Linguistic Review Case Study
About the project
The client has a set of pharmacology documents that need to be reviewed. The documentation is intended for submission to National regulatory authority in order to gain approval to market the pharmaceutical product. As the files contained lots of medicine, pharmacology and chemistry terms, we must make sure that all terms are translated consistently and in-line with the industry standard terminology; The translation requires exactness, accuracy, and absolute correctness. We should avoid complex language structures, loose/vague formulations and jargon/informal language.
- Review the files and insert translation suggestions/comments into the provided QA form
- Make sure that the translated text is an accurate translation of the source, that it is correct from the language point of view and that it reflects the target standards/culture and is suitable for the target audience.
- Always remember to classify the errors in terms of category and severity.
- Use the reference material for terminology, especially checking headings, list of excipients, undesirable effects, etc.
- Follow the specified country standards when using symbols, units of measurements, numerals, etc.
- As the client provides medical solutions, they are very demanding for the quality of translation and require exactness, accuracy, and absolute correctness. We used our best German to Chinese translator who is a senior editor in a famous medical newspaper agency to performed linguistic review for the translated file.
- All documents for review were created from PDF files by using OCR technology, we made great effort in checking spelling, character and special character mistakes during reviewing.
- The client provided a standardized international medical terms approved by international medical authorities to us. We strictly followed the industry standard terminology for technical terms.
- We checked the formatting parameters, run a spell-check and completed QA form before delivery. This whole reviewing process we performed including check that the meaning has been conveyed, there are no omissions or errors and that the defined service specifications have been met.
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