Prescription medications require all types of informative documentation to successfully get products approved for sale in global markets, making Package Information Leaflets (PILs) translations a crucial step for regulatory submission process. Package Information Leaflets are documents that detail usage instructions, potential benefits, and the inherent risks of a particular medication, with additional information on the strength of the product, description of side effects, and how to store the product safely. Under European, UK, and US regulations, Package Information Leaflets are not only required, but also have strict guidelines for the readability and the language used to display important information. To help manufacturers in reaching new markets and patients globally, CSOFT Health Sciences offers accurate and high-quality Package Information Leaflets translations across 250+ languages.
In addition to Package Information Leaflets translations, our global network of 10,000+ linguists and subject matter experts specialize in translations of documents required in pharmaceutical dossiers, including summary of product characteristics (SmPC) translations, chemical, manufacturing, and control (CMC) document translations, drug product labeling translations, and risk management plan (RMP) translations.
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Drug Product Labeling Translations
New pharmaceutical product labels contain crucial information that needs to be available in a wide range of languages to ensure that someone of any background can safely receive medication. Drug products labels include prescription labels and over the counter (OTC) labels with each type displaying important safety information and details of the products ingredients. For prescription labels, information on the dosage, dosage schedules, prescribing doctor, and date filled are included within the product itself. For OTC labels, the drug facts are printed directly on the medication and include details such as the active and inactive ingredients, usage instructions, and safety warnings. High-quality and accurate translations for all types of drug product labels are essential for any company working the global pharmaceuticals market. CSOFT Health Sciences offers a full range of localization solutions for the drug product labeling process, including chemical, manufacturing, and control (CMC) translations and summary of product characteristics (SmPC) translations.
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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.
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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.