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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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Home 9 Regulation and Legislation Translations

Regulation and legislation translations are essential to ensuring compliance and providing safe and high-quality services to clients on a worldwide basis. 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 for customers throughout the world, keeping up with regulation and legislation 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.

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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