PRE-IND/NDA CDE MEETING Interpretation
Enter the Chinese Market with CDE Meeting Interpretation
The NMPA’s Center for Drug Evaluation and Research (CDE) regulates the entry of over-the-counter and prescription drugs into China’s pharmaceutical market, including biological therapeutics and generic drugs already approved by other regulatory bodies, such as the U.S.’ Food and Drug Administration (FDA). Pre-application Investigational New Drug (IND)/New Drug Application (NDA) meetings with the CDE can help establish a relationship between life science companies and the regulatory agency before approval. CSOFT Health Sciences’ expertise in interpreting and medical translation can ensure accurate and timely multilingual communication for every CDE meeting.
Benefits of pre-IND/NDA meetings with the CDE
INDs and NDAs are notoriously a timely and costly process. Scheduling an advance meeting can help:
- Prioritize your application for regulatory approval
- Provide in-depth, contextual understanding of the CDE’s requirements
- Ensure the regulatory agency has ample time to prepare resources for the upcoming submission
While CDE pre-IND/NDA meetings are not necessarily required, they can help save time, money, and energy in the regulatory approval process. To ensure an effective meeting, CSOFT Health Sciences’ high-quality and accurate translation is essential for clear communication and understanding between both parties.
How Our End-to-End Solutions Help
CSOFT Health Sciences’ linguistic experts provide interpretation for your CDE meetings live on-site or remotely, assuring the quality, speed, and effectiveness of your communication. With in-depth knowledge of China’s regulatory body and requirements, we ensure that you are more than prepared for the meeting and able to petition for the best possible outcome for your medical device or drug therapy, all while providing expert translation solutions throughout the process.
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As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering 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 to 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 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
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