As China's National Medical Products Administration (NMPA) transitions to eCTD (electronic Common Technical Document) submissions, pharmaceutical companies face new challenges in adapting to these regulatory changes. At Willingjet, we leverage our expertise to help clients navigate this process effectively, ensuring smooth and accurate submissions.
Richard, the head of our eCTD team, brings over 10 years of experience, including his tenure at Pfizer, to guide clients through the intricate steps of eCTD implementation. Our services cover key aspects such as:
Submission Compilation and Publishing.
Report Publishing.
eCTD Transition
Regulatory Strategy & Operation Consulting.
We are dedicated to providing practical solutions, enabling our clients to transition confidently into the eCTD era.
To foster industry-wide understanding and adoption of eCTD submissions, we have launched the Regulatory Operation Knowledge Workshop series. These sessions, led by Richard and our expert team, have been well-received by regulatory professionals in China. Hosted on our "Willingjet Medical Translation" video channel, the series has already covered 30 topics, including:
Fundamentals of eSubmission & eCTD: Key concepts, types, and the benefits of electronic submissions.
Specification & Validation Criteria: Detailed insights into the China eSubmission and eCTD requirements and validation standards.
Practical Application: Tips for improving document preparation and submission accuracy.
These workshops have empowered participants to develop a solid understanding of eSubmission and eCTD, bridging the gap between theoretical knowledge and practical application.
Willingjet has become a recognized resource for regulatory professionals in China. Our articles, videos, and workshops have attracted a growing audience, demonstrating our commitment to sharing knowledge and supporting the industry.
With eCTD implementation in China, Willingjet will continue to provide expert guidance, expand our training initiatives, and develop tailored solutions to address client needs. Our goal is to help clients achieve compliance efficiently and effectively.
For pharmaceutical companies facing the challenges of eSubmission and eCTD submission, Willingjet offers expertise and unwavering support to make the transition as smooth as possible.
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