The NMPA’s Center for Drug Evaluation and Research (CDE) regulates the entry of over-the-counter and prescription drugs into Asian pharmaceutical markets, 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) and 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 timely and costly. Scheduling an advance meeting can help:
- Prioritize your application for regulatory approval
- Provide an 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 your communication’s quality, speed, and effectiveness. With in-depth knowledge of Asia’s regulatory bodies and their specific requirements, we ensure that you are prepared for all regulatory challenges and can petition for the best possible outcome for your medical device or drug therapy in the language required.
Learn more about our consulting and translation services for the NMPA.
We interpret:
- Clinical trial design
- CMC
- Popular markets
- Proposals
- New innovations
Consecutive and Simultaneous Interpretation
Whether over the phone or on video, those needing interpretation services for their CDE meetings will have to choose between the two major methods of interpretation – consecutive or simultaneous. Consecutive interpretation is what people usually think of when they imagine an interpreter, in which the person whose speech they are translating finishes a thought before the interpreter interjects with their translation. Simultaneous, however, is done while the speaker is still talking, providing a fluid translation in time with the speaker’s speech. For companies and organizations in the life sciences, consecutive and simultaneous interpretation can mean the difference between expanding into a new market and being stopped at the regulatory level. If it is not done right, the consequences can be catastrophic.
CSOFT Health Sciences’ team of qualified interpreters has in-depth experience in the industry and an understanding of any target audience’s cultural nuances and language. Thus, we enable companies to pursue new markets while ensuring regulatory compliance and their customers’ health and safety.
Learn more about our simultaneous and consecutive interpretation services.
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.
