Gaining regulatory approval for drugs and medical devices is a daunting process. As the increasing rate of diagnoses of genetic diseases creates demand for products such as genetic tests, the need to successfully navigate new regulatory processes has become increasingly important. CSOFT offers comprehensive regulatory consulting services for companies seeking to access new markets, from determining product requirements and analyzing market intelligence to strategizing the most effective way to obtain regulatory approval.
To develop drugs therapies for genetic diseases, conducting clinical trials and recruiting patients are some of the most important aspects of the drug development process. As the global clinical trials market shifts to more international locations, ensuring linguistically accurate and culturally appropriate recruitment material and trial documentation such as consent forms and clinical study protocol is vital. CSOFT’s global network of linguists and subject matter experts provide translation and localization solutions for clinical trials across 250+ languages. Learn more
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 compliant with ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
End-to-End Communication Solutions
CSOFT can help companies specializing in genetic disease therapeutic areas gain access to new markets and meet regulatory standards. Specifically, we specialize in the following areas:
Professional, high-quality localization of a service or product is critical for translation solutions in Spanish, particularly in the life sciences as one bad translation can be life threatening. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance special to the life sciences that includes linguistic validation 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 that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 9001:2015 and ISO 13485:2016 and our operations are compliant with ISO 17100 to ensure our customized solutions meet Spain’s regulatory requirements.