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.

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Home 9 Package Label and Insert Translations

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.

Learn more about our full coverage translations needed for drug product labeling.  

Pharmacovigilance Translations

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.

Learn more about our pharmacovigilance translations.

Medico-Marketing Translations

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.

Learn more about our medico-marketing translations.

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Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

High Quality Academic Translations

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