Prescription medications require all types of informative documentation to successfully get products approved for sale in global markets. Package Information Leaflets (PILs) translations are a crucial step in the 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.
Learn more about our translations for pharmaceutical dossiers.
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 product labels include prescription and over-the-counter (OTC) labels, each displaying important safety information and details of the product’s 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 drug product labels are essential for any company in 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) document translations and summary of product characteristics (SmPC) translations.
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Instructions for Use (IFU) Translations
Instructions for Use (IFUs) provide critical usage information to patients for medical devices and drugs. As life sciences companies expand globally, translating IFUs into local languages is crucial for market entry. Regulators mandate translated IFUs to ensure proper patient safety and compliance overseas. With growing digital IFUs containing videos, flawless localization is vital. Our expert linguists deliver clear, accurate IFU translations on tight timelines, enabling clients to launch compliant medical products worldwide. We help avoid dire consequences of mistranslation, like market rejection, brand damage, fines, and legal action. Our precise IFU translations facilitate patient safety and global market access.
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Medico-Marketing Translations
As the global pharmaceuticals market continues to expand into to new regions of the world, effective medico-marketing strategies to promote brand and product awareness and enhance product image are needed across multiple languages. Medico-marketing not only involves the promotion of pharmaceutical products to patients but is also essential for selling products in healthcare settings, like hospitals, clinics, and nursing facilities. This process involves creating a wide variety of patient-centric content and material that must be available in multiple languages for distribution in international markets. CSOFT Health Sciences provides medico-marketing translations for the pharmaceuticals industry, including high-quality digital medico-medical marketing translations and eLearning translations for medico-marketing.
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Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.