Gain UK and European Regulatory Approval with SmPC Translations
European (EU) and United Kingdom (UK) 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, such as the EU’s European Medicines Agency (EMA), 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 SmPC as new data is collected through research. To help pharmaceutical companies gain marketing authorization for new products, CSOFT Health Sciences leverages a global team of over 10,000 subject matter expert linguists to offer accurate and high-quality SmPC translations.
Dossier Translation Services
Dossier translations help pharmaceuticals and medical device companies, CROs, and academic institutions ensure that new health products gain regulatory certification in time for approval before market, in all the languages required for a specific regulatory environment. A clinical trial dossier translation is an important collection of documents that is presented before a regulatory agency to gain authorization for a new medical device or drug therapy. CSOFT Health Sciences offers a full range of translations for documents required in pharmaceutical dossiers, including chemistry, manufacturing, and control (CMC) translations, package information leaflets (PILs) translations, and risk management plan (RMP) translation In 250+ languages.
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Regulatory Translations for the Life Sciences Industry
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.
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Regulatory Translations for the Life Sciences Industry
Life sciences companies face some of the strictest regulatory requirements of any industry and supporting these companies with high-quality translations for regulatory submissions is essential for success in global markets. Regulatory agencies including the European Medicines Agency (EMA), China’s National Medical Product Administration (NMPA), and the US Food and Drug Administration (FDA) have varying timelines, language requirements, and formatting standards for all types of documents needed for approving new products. CSOFT Health Sciences offers a full range of localization solutions for gaining regulatory approval in 250+ languages, including industry-specific regulatory translations like biotech translations, pharmaceutical translations, medical device translations, chemical translations, public health translations, and hospital translations.
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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.
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