Package Label and Insert Translations
CSOFT Health Sciences provides high quality and accurate package label and insert translations to help pharmaceutical manufacturers ensure their products correctly display prescribing information in any language.
When entering new markets, pharmaceutical companies are required to display prescribing and dosage information in the labels and inserts of their products, making package label and insert translations crucial to any company working internationally. For prescription medications, package labels and inserts detail prescribing information (PI), including the description of the product, the clinical pharmacology, contraindications, adverse reactions, dosage and administration instructions, and more. In the global pharmaceuticals market and according to different international regulations, package labels and inserts are required to be translated into the native language of the targeted market. To help pharmaceutical companies reach new customers and remain in compliance with regulations of drug safety, CSOFT Health Sciences offers a full range of high quality and accurate translations for package label and inserts.
In addition to package label and insert translations, we provide translations for various different document types essential for the manufacturing, packaging, and labeling of medications, including Summary of Product Characteristics (SmPC) translations, Package Information Leaflets (PILs) translations, Risk Management Plan (RMP) translations, Chemical, Manufacturing, and Control (CMC) document translations, and Instructions for Use (IFU) translations.
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In the pharmaceuticals industry, pharmacovigilance is an important branch of pharmacology that focusses on the monitoring, analyzing, reporting, and prevention of any adverse drug reactions (ADRs) to new products. Before any pharmaceutical product can be used, the manufacturers must be able to produce evidence on the safety and efficacy of their product through submitting pharmacovigilance documents to the overseeing regulatory agency. As more companies expand their sales internationally and reach new customer bases, accurately reporting ADRs from anywhere in the world demands high quality and accurate pharmacovigilance document translations. From adverse event (AE) documents to individual case study reports, CSOFT Health Sciences provides expert translations for all types of documents required for drug safety reporting.
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Following the manufacturing of a new pharmaceutical product, medico-marketing involves the process during which the drug developer promotes their new product to doctors, nurses, pharmacists, and patients. With the main objective to increase awareness of the product and promote brand identity, medic-marketing is an important step in the lifecycle of any product. For pharmaceutical companies, this process involves preparing all types of materials, such as brochures, product dock slides, patient education manuals, training manuals, and more. To hep companies increase brand awareness overseas and promote their product to any customer base, CSOFT Health Sciences provides cost-effective translations for all types of materials and content necessary for medico-marketing.
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As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
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