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Pre-Ind/NDA CDE Meeting Interpretation

CSOFT Health Sciences provides the highest-quality CDE meeting interpretation services from the early stages of approval through post-launch communication

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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
ISO-certified Academic Translations

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 and 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 7 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 translation memory and terminology management in real time through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.

High Quality Academic Translations

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