Summary of Product Characteristics (SmPC) Translations

We specialize in expert Summary of Product Characteristics (SmPC) translations to help pharmaceutical companies through international regulatory approval processes.

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Home 9 Summary of Product Characteristics (SmPC) Translations

International regulations to gain marketing authorization for approved medicines outline specific language requirements which makes Summary of Product Characteristics (SmPC) translations essential for companies looking to reach new markets. Summary of Product Characteristics (SmPC) are legal documents submitted to regulatory bodies within a dossier that provide information on the intended use of the medicine, method of administration, warnings and precautions, and therapeutic indications such as the disease or condition the medication is designed to target. Throughout the lifecycle of the medication, pharmaceutical companies can update the information included in the Summary of Product Characteristics as new data is collected through research. To help pharmaceutical companies gain marketing authorization for new products, CSOFT Health Sciences offers accurate and high-quality Summary of Product Characteristics (SmPC) translations.

In addition, CSOFT Health Sciences offers a full range of translations for documents required in pharmaceutical dossiers, including chemical, manufacturing, and control (CMC) document translations, package information leaflets (PILs) translations, and risk management plan (RMP) translations. 

Learn more about our translations of documents required in pharmaceutical dossiers.

Drug Product Labeling Translations

New pharmaceutical product labels contain crucial information that needs to be accurately and efficiently displayed to gain marketing authorization and have new therapies approved for international use. 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 package information leaflets (PILs) translations and instructions for use (IFU) translations.

Learn more about our drug product labeling translations.

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
ISO-certified Academic Translations

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.

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