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.
Learn more about our consulting and translation services for the NMPA.
We interpret:
- Clinical trial design
- CMC
- Popular markets
- Proposals
- New innovations
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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain 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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
