Life sciences regulatory translations often serve as an essential step for gaining approval for new therapies, devices, or products in overseas markets today. Regulatory bodies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) require detailed data and information to be submitted for approval within specific timelines. Especially in the case of multinational regulatory submissions or clinical trials, effective regulatory translations for all documentation is critical for gaining approval and successfully bring a product to new global markets.
With a global network of 10,000+ linguists and subject matter experts in areas including CRO regulatory translations, clinical trial regulatory translations, and in-vitro diagnostic device (IVD) regulatory translations, CSOFT Health Sciences offers a full range of localization solutions for life science regulatory translations including:
Life Science Chemical Regulatory Translations
The chemical sector also remains one of the most regulated within the life sciences, with strict laws and guidelines in place to protect both humans and the environment. To navigate these regulations and successfully expand into new global markets, chemical regulatory translations for all required documentation in an effective solution for adhering to international chemical and environmental safety regulations. CSOFT Health Sciences provides localization solutions for sectors of the global industrial chemical supply chain, including biochemical regulatory translations, petrochemical regulatory translations, materials science regulatory translations, plastics manufacturing regulatory translations, and agricultural chemical translations
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Medical Device Regulatory Translations
The medical device sector relies on modern medical technology to treat diagnose and prevent diseases and conditions. To be able to compete in overseas markets, medical device manufacturers have to go through a regulatory approval process that ensures that the safety, efficacy, and documentation for their product is compliant with global regulations. CSOFT Health Sciences provides medical device localization solutions for medical device manual regulatory translations, instructions for use translation (IFU) regulatory translations, medical device document regulatory translations, medical device software regulatory translations, and more.
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CE Marking Translations for the Life Sciences
CE Marking, also referred to as a European Trade Passport, is an important step in gaining market access in the European Economic Area (EEA). The CE mark signifies that a product is verified and compliant with consumer and environmental protection standards regarding public health and safety. For CE Marking, accurate translation of technical documents is critical to conform with approved safety evaluations and measures, as well as to gain regulatory approval in the EEA.
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Good Documentation Practices (GDP) for Regulatory Translations
Good Documentation Practices (GDP), also referred to as GDocP, describes a set of standards that are designed for the pharmaceutical and medical device industries and required by most regulatory bodies including the FDA, EMA, TGA, and more. These procedures are typically carried out electronically, and mandates for life science companies to keep a variety of documented records throughout the product’s lifecycle. High quality medical translation of these documents is essential for international regulatory compliance.
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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.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
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As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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