Regulatory Submissions Language Services

For life science companies competing in global markets, CSOFT’s regulatory submissions language services ensure successful applications to the FDA, EMA, NMPA, and regulatory bodies worldwide

Clinical trials are expensive and multi-faceted, entailing a vast need for language services to support multilingual translation of regulatory submissions region-by-region as required by law. As it is very common for life science companies to outsource pivotal trials and submissions as an efficient method to reduce costs, the need for accurate and efficient language services from a trusted language service provider is also shared by organizations like CROs when conducting multilingual, decentralized clinical trials across borders.

For instance, to market a new product in Europe that was manufactured in the United States, the product may need to be translated into one of the 24 tongues that make up the European Union’s official languages, as directed by the EU CTR and EU MDR policies. Before that new product can ever be marketed, there are many further obstacles to overcome, such as guidelines and regulations for each of the countries in which these trials are conducted. The process of localization is complicated but critical, as mistakes can be catastrophic and could result in a product’s failure in the regulatory process or, worse, harm to its intended audience.

CSOFT’s experienced and dedicated global regulatory submission language service specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality, helping to ensure the safety of all stakeholders and customers involved.

Regulatory Submission Globalization Services

We can help you attain the appropriate, accurate, and sustainable compliance required throughout the entire submission process.

As a company certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 and leveraging best practices of ISO 27001, we ensure our clients receive the necessary certifications to successfully enter emerging markets.

Quality Assurance

Quality Assurance

Professional, high-quality localization of a service or product is critical for translation solutions in 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 remain in one centralized location, updated in real time, to ensure CSOFT has you covered every step of the way. Additionally, we are certified in ISO 17100:2015ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet global regulatory requirements and our clients’ highest expectations for quality.

Learn more about our quality assurance processes.

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 security processes leverage best practices from ISO 27001, ensuring we adhere to the latest international standards in information security.

Learn more about CSOFT’s data security procedures.

Data Security

Speak to us today!

For more information on how CSOFT can assist you with your translation requirements, please contact us through this website, or call us at +1-617-263-8950.

Are you conducting a translation RFP or tender? We love RFPs.

Please click here to send us your RFP.

Got questions?

Speak to one of our support agents.