End-to-End Regulatory Translations
Life sciences regulatory translations often serve as an essential step for gaining approval for new therapies, devices, or products in overseas markets. 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, often across multiple languages, within specific timelines. Especially in the case of multinational regulatory submissions and multilingual 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 translations, clinical trial translations, and in-vitro diagnostic device (IVD) translations, CSOFT Health Sciences offers a full range of localization solutions for life science regulatory translations including:
Life Science Chemical Regulatory Translations
The chemical industry remains one of the most regulated within the life sciences, with strict laws and guidelines for chemical translations 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 many sectors of the global industrial chemical supply chain, including biomedical engineering translations, biomaterials translations, plastics manufacturing translations, and agrochemical translations.
Learn more about our life science chemical translations.
Medical Device Regulatory Translations
The medical device sector relies on modern medical technology to treat diagnose and prevent diseases and conditions, making medical device translations crucial for providing care across languages. To compete in overseas markets, medical device manufacturers must go through a regulatory approval process that ensures that the safety, efficacy, and documentation for their product is compliant with regulations for each local market. CSOFT Health Sciences provides medical device localization solutions for medical device manual translations, instructions for use translation (IFU) translations, medical document translations, medical device software translations, and more.
Learn more about our medical device translations.
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), requiring accurate and timely CE marking translations. 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. CSOFT Health Sciences’ linguists have a minimum of 7 years’ experience to ensure that their medical translations meet regulatory guidelines in 250+ languages.
Learn more about our CE marking translations.
Good Documentation Practices (GDP) for Regulatory Translations
Good documentation practices (GDP/GDocP) describe 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. With a global network of over 10,000 in-country linguists and subject matter experts with proven experience localizing documents for the medical devices and pharmaceuticals industries, CSOFT Health Sciences provides end-to-end translations for a wide range of GDP/GDocP documents.
Learn more about our good documentation practices translations.
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.
Learn more about our quality assurance process.
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.
Learn more about how CSOFT prioritizes data security.