Regulation and Legislation Translations

We provide regulation and legislation translations to ensure compliance with global standards and to provide safe services to clients across the world.

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Regulation and legislation translations are implemented to ensure compliance and to provide safe and high-quality services to clients. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you are a pharmaceutical company, medical device company, U.S Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulations and legislations ensure safety of product use such as drugs, vaccines, biological medical products, medical devices, and radiation-emitting products. As companies and organizations continue to release products into new markets and reaching customers throughout the world, keeping up with regulations and legislations is necessary to meet customer needs. To help life sciences maintain consistency in quality of products for the targeted audience, CSOFT Health Sciences provides accurate translations for regulations and legislations. With a global network of in-country linguists and expertise to translate over 250 languages, we can help localize different types of regulations and legislations, including:

  • Federal Food, Drug, and Cosmetic Act Translations
  • Affordable Care Act Translations
  • Health Insurance Portability and Accountability Act (HIPAA) Translations
  • FDA Title 21 Regulation Document Translations
  • ISO Compliance Regulation Document Translations
  • EU Pharmaceutical Legislation Translations
  • EU Regulation Document Translations
  • Medicare and Medicaid Translations
  • Drug Registration Regulation Document Translations
CSOFT additionally provides certified translation services that ensure that there is no misinterpretation when translating regulation and legislation documents. Companies can interpret regulation and legislation accurately with the services to conform to requirements that can improve quality of client services.

Learn more about our Certified Translation Services.

Localizing Your Regulation and Legislation Translation Needs by Industry

Regulation and legislations have become the primary source for ensuring that medical products are safe to use and able to reach new markets. For any life science company, translations for regulation and legislation documents enable companies to produce new safe products and connect with customers and organizations across the world. There are numerous ways to connect, whether it is regulation and legislations for medical devices to ensure that manufacturing to regulation is tailored to specific markets, companies all around the world require regulation and legislation translations to successfully manufacture and share products to markets. CSOFT Health Sciences provides regulation and legislation translations to various life science industries, including:

Medical Software System Guidance Translation

Medical software products need to align with regulation and legislations to expand their products and services across the market. The US Food and Drug Administration (FDA) is involved with product guidance and how to effectively develop new medical products. Companies across the world can use medical software system guidance translations to have a better understanding of developing medical software systems and to ensure quality and safety of products. CSOFT Health Sciences provides accurate translations for companies developing medical software systems in 250+ languages

Learn more about our Medical Software System Guidance Translations

Pharmaceutical Product Guidance Translation

Pharmaceutical products need to align with regulation and legislation for companies to expand their products to new market. These products need to be developed to provide safe health care services while in compliance. US Food and Drug Administration (FDA) are involved with product guidance to ensure products are safe to use. Companies across the world can use pharmaceutical product guidance translations to have a better understanding of developing pharmaceutical products that gear to improve health outcomes and ensure safety. CSOFT Health Sciences provides accurate translations for companies developing pharmaceutical products and expanding them to the international markets.

Learn more about our Pharmaceutical Product Guidance Translations.

ISO-certified Academic Translations

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

High Quality Academic Translations


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