Instructions for Use (IFUs) are informative patient-facing labels on medical devices and pharmaceutical products. IFU translations are essential for medical products being developed for international markets. The information in an IFU guides the proper use of a medication or device, informing patients of necessary precautions they should take or helping simplify complex dosing instructions as the world has become increasingly digital. An electronic IFU format (eIFU) is becoming more prevalent. eIFUs contain audio and video files that enable life science companies to more effectively demonstrate how to correctly handle medical products. For life science companies expanding overseas, highly accurate and timely IFU translations are vital since most regulatory agencies (such as the FDA, EMA, and NMPA) require IFUs and eIFUs to be translated into the market’s primary language before gaining market approval. Failing to provide an accurate IFU or eIFU translation can result in loss of market access, negative brand impact, and even legal consequences like fines, lawsuits, and imprisonment. CSOFT’s global network of 10,000+ in-country linguists and subject matter experts, along with our quality assurance process and video translation services, provides life science companies with high-quality and timely IFU and eIFU translations to ensure regulatory compliance and the best ROI.
Package Label and Insert Translations
With a growing demand for medical devices and pharmaceutical products across the globe, package labels and insert translations are essential to meet regulatory standards. In addition, advancements in pharmaceutical products have allowed patients to maintain a healthy lifestyle and protect global public health. CSOFT Health Sciences ensures regulatory compliance to access foreign markets while providing the highest-quality package label and insert translation and localization solutions across 250+ languages.
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Regulation and Legislation Translations
High-quality regulation and legislation translations are crucial to ensure that medical devices and pharmaceutical products are safe for patients across the globe. Whether you are a pharmaceutical company, a medical device company, U.S Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulation and legislation translations help ensure the safety of product use such as drugs, vaccines, biological, medical products, and medical devices in international markets.
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Ensuring Drug Safety Through Precise Pharmacovigilance Translations
Pharmacovigilance involves closely monitoring new pharmaceuticals to detect adverse reactions. Manufacturers must submit evidence of safety and efficacy to regulators through pharmacovigilance documents. As companies expand globally, they need accurate translations to promptly and accurately report adverse events from all regions. Pharmacovigilance reports must be localized flawlessly for pharmaceuticals to safely reach new markets and populations. Our specialized translators enable precise communication between drug makers and oversight agencies by expertly translating adverse event cases, individual safety reports, and all documentation required for pharmacovigilance worldwide. We enable global pharmaceutical companies to fulfill pharmacovigilance duties through clear, compliant 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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. 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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
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