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Pharmaceutical and medical device translation requires not only medical and linguistic knowledge but also an understanding of strict industry standards and regulatory frameworks.
Documents translated include:
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PRODUCT LIFE CYCLE
My translation work spans the entire life cycle of the pharmaceutical product: research and development, clinical trials, regulatory affairs, inspections, reports, approvals, labeling, packaging, quality and testing, postmarketing surveillance, and pharmacovigilance.
LABEL UPDATES FOR DIRECT FACTOR XA INHIBITOR
I recently translated Chinese-language updates for black box warnings and adverse reactions in the prescribing information for an anticoagulant drug, specifically a direct factor Xa inhibitor drug.
LABEL UPDATES FOR IMMUNOMODULATOR DRUG
In compliance with the FDA's risk evaluation and mitigation strategies program, I translated recent updates associated with pregnancy and serious adverse events in the Warnings and Indications section of the label for an immunotherapy agent.
REVIEW ARTICLE ON THE ROLE OF ASPIRIN IN PRIMARY PREVENTION
I also translated a Chinese review article on data from three large clinical trials in 2018 suggesting the need for a reappraisal of the role of aspirin in the primary prevention of cardiovascular disease.
My translation work spans the entire life cycle of the pharmaceutical product: research and development, clinical trials, regulatory affairs, inspections, reports, approvals, labeling, packaging, quality and testing, postmarketing surveillance, and pharmacovigilance.
LABEL UPDATES FOR DIRECT FACTOR XA INHIBITOR
I recently translated Chinese-language updates for black box warnings and adverse reactions in the prescribing information for an anticoagulant drug, specifically a direct factor Xa inhibitor drug.
LABEL UPDATES FOR IMMUNOMODULATOR DRUG
In compliance with the FDA's risk evaluation and mitigation strategies program, I translated recent updates associated with pregnancy and serious adverse events in the Warnings and Indications section of the label for an immunotherapy agent.
REVIEW ARTICLE ON THE ROLE OF ASPIRIN IN PRIMARY PREVENTION
I also translated a Chinese review article on data from three large clinical trials in 2018 suggesting the need for a reappraisal of the role of aspirin in the primary prevention of cardiovascular disease.
MEDICAL DEVICE TRANSLATIONS
Image credit Stent Vectors by Vecteezy
Translation of instructions for use (IFU), ranging from endoprostheses, coronary stents, drug-eluting stents, and endovascular stents to surgical sutures, mesh plugs, ostomy devices, biopsy cannulas, and diagnostic reagent kits.