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Regulatory Translation

We provide life science companies highly-accurate regulatory translations to ensure compliance and market access

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Across life science industries, meeting regulatory compliance standards is an essential step in gaining market access, making regulatory translation a hugely important investment. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) all require data and documentation to ensure the efficacy and safety of products entering the local market. To gain regulatory compliance, accurate translation of regulatory documentation and data is critical for life science companies to be successful when expanding overseas.

Regardless of the industry, CSOFT helps life science companies meet the rigorous regulatory demands of global submissions through our localization best practices, network of over 10,000 in-country professional linguists and subject matter experts, as well as our advanced language technology. We have experience translating:

CE Marking Translations

CE Marking is an important step in gaining market access in the European Economic Area (EEA). The mark signifies that a product is verified and compliant with consumer and environmental protection standards regarding public health and safety. For CE Marking, a collection of documents referred to as a technical file that contains documentation, such as a description and a bill of materials, is required to be submitted for an assessment. Accurate translations of these 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 specializes in translations for all types of regulatory documentation for life science industries, including pharmaceuticals regulatory translations, chemical regulatory translations, and biotechnology regulatory translations.

Learn more about our CE Marking translations.

Multilingual Clinical Trial Translations

Clinical trials are an essential element of the drug development process. As the demand for pharmaceutical drugs increases overseas, more and more clinical trials are conducted in countries where English is not the dominant language. To satisfy regulatory compliance and meet recruitment targets, using high-quality and accurately translated and localized clinical trial documentation and patient recruitment material is essential for successful clinical trials. CSOFT Health Sciences provides culturally appropriate and accurate translation services for pharmaceutical companies, covering all types of documents, including phase 0-IV clinical trial documentation, patient recruitment documentation, Trial Master File (TMF) documentation, and clinical trial protocol documentation. 

Learn more about our translation services for multilingual clinical trials.

MDR Translation Services

The implementation of the European Union’s Medical Device Regulation (MDR) brings new challenges to the medical device industry, including greater responsibility for post market surveillance, creating a summary of safety and clinical performance for Class III and implantable devices, as well as expanding the definition of a medical device to include software and applications. With the transition period set to end in 2025, medical device manufacturers must adhere to the changes in the regulation to maintain and gain market access in the European Economic Area (EEA).Utilizing our in-country linguists and subject matter experts, CSOFT Health Sciences supports medical device companies expanding into the EEA to meet regulatory compliance standards. We have experience translating technical documents that now, under the new MDR, require translation before receiving CE markings, as well as eLearning materials to train staff on updates to regulatory compliant manufacturing processes and data collection formatting and procedures. Our global network of linguists and subject matter experts specialize in translations to support compliance with the MDR, including instructions for use (IFU) translations, package inserts and labels translations, and class I-class III medical device translations.

Learn more about our MDR translation services for medical devices.

Good Documentation Practices (GDP) 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 is 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.

Learn more about our Good Documentation Practices (GDP) Translations.

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.

Learn more about how CSOFT prioritizes data security.

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.

Learn more about our quality assurance process.


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