Drug product labels, also known as prescription labels, contain information about the pharmaceutical product’s manufacturer, directions for use, dosage, expiration date, lot number or batch number, timing, and method of administration, making accurate drug product labeling translations essential to capturing this information clearly across markets. In general, there are two types of drug product labels: over-the-counter (OTC) labels (also known as Drug Facts), and prescription labels. For OTC drugs, the Drug Facts are directly printed on the product itself, and provide information about inactive ingredients, active ingredient and purpose, directions, uses, warnings, other information, and sometimes a questions or comments section. Unlike OTC labels, prescription drug labels are more complex and varied, and can contain information about the medication dosage, dosing schedules, the prescription’s identification, date filled, and the prescribing doctor and pharmacist who filled the label. In addition, drugs can also come with auxiliary warning labels, which provide additional information about how to safely store and administer the medicine. Beyond the information found on the drug product itself, pharmacy information sheets, prescribing information (package inserts), and medication guides also contain important information on dosing and ingredients.
As the demand for pharmaceutical products grows in overseas markets, all labels and information for OTC and prescription drug labels must be translated with extreme accuracy; failure to do so can lead to loss of market share, production delays, and negative brand image. CSOFT Health Sciences’ global network of 10,000 linguists and subject matter experts (SMEs) provide highly accurate and timely translations of OTC labels, prescription labels, auxiliary labels, drug study labels, pharmacy information sheets, package inserts, and medication guides to help life science companies expand into new markets with confidence.
Package Label and Insert Translations
Drug labels provide users with important information on dosage, warnings, as well as active and inactive ingredients. Beyond the labels on the packaging itself, drug product labeling can also include documents like pharmacy information sheets, package inserts, and medication guides. These documents give patients vital information on black box warnings, contraindications, adverse interactions, and even uses in specific populations. As research is increasingly being conducted into the impacts of drugs on diverse populations, providing accurate package label and insert translations are not only vital for gaining market access, but also for informing different groups that have limited English proficiency (LEP) so they can be more empowered to make the right choices about their health. CSOFT Health Sciences’ global network of 10,000 in-country linguists and subject matter experts (SMEs) accurately and quickly translate over-the-counter (OTC) and prescription labels, auxiliary labels, and documentation such as pharmacy information sheets, medication guides, and package inserts in more than 250 languages.
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Drug Study Label Translations
In pharmaceutical clinical trials, drug study labels are used to give trial sponsors, patients, and doctors the medicine’s unique subject identifiers, expiration date, potency, batch number, expiration date, and storage requirements. In addition, the drug trial label clearly describes the clinical trial participant, the study associated with the drug, and the drug itself. Before the trial can begin, clinical trial drug labels must receive approval by the relevant regulatory body, must be translated into the country’s official language, and must be permanently fastened to either the immediate packaging or outer packaging.
As the demand for pharmaceutical products grows worldwide, more and more clinical trials are being conducted in countries where English is not the primary language. Failure to provide accurate translations of drug study labels can lead to regulatory delays, loss of market access, wasted resources and money, as well as potentially endanger patient lives. CSOFT Health Sciences provides highly accurate and timely translations for drug study labels to ensure that life science companies maintain regulatory compliance and receive the best ROI.
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Pharmaceutical Product Dossier Translations
To successfully gain marketing authorization for a new pharmaceutical product, companies are required to submit a dossier which contains crucial drug safety information, details on the product development, clinical trials documents, and
drug product labels. Depending on where the new product will be brought to market, regulatory agencies have strict language requirements for all the documentation compiled within a dossier, which makes accurate and efficient translations of dossier content essential for pharmaceutical companies. From Summary of Product Characteristics (SmPC) translations and Chemical, Manufacturing and Control (CMC) documents translations to phase 0-IV clinical trial document translations, CSOFT Health Sciences offers a full range of translations for all types of documents required for dossiers and necessary for
safely bringing a new product to market.
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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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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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