CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Establishing a Center of Excellence (CoE) for China eCTD Submissions
Project Summary
A US-based top 10 global pharmaceutical company in preparation for the eCTD submissions to the China market was exploring a long-term strategic partner to support end-to-end eCTD publishing and submissions along with translation and coordination services.
Celegence Solution & Approach:
Celegence was awarded a multi-year contract to strategically partner with the customer in establishing and executing business processes for China eCTD submission. The following solution steps and approaches were considered to support this project by Celegence. Celegence was awarded a multi-year contract to help this customer with the business process related activities, including process definition & execution of the following activities:
Highlights:
Dual language and Time zone: Established a delivery model with a nearshore workforce in China for time zone and language coverage.
Regulatory Center of Excellence: A CoE team established in Celegence’s delivery center in Bengaluru, India to execute the project scope of activities in a record time. CoE comprises skilled word and PDF publishers, global submission subject matter experts, hands-on tools and technology experienced resources, and an efficient leadership team for governance.
Submission Strategy: Effective submission strategy by creating well-defined process flows, thorough documentation, quality gates, and governance model.
Secure Workspace: A highly secure work environment connecting to client’s databases through secure virtual private network complying to data security and privacy policies of both the partners.
Project Achievements
A detailed impact analysis of the eCTD requirements and advisory on gap remediation.
A comprehensive training to the client’s stakeholders in the Chinese language with deep dive details on the technical specifications and submission guidelines from China NMPA and ICH.
Established of end-to-end processes for submission publishing inclusive of document publishing, submission-ready publishing, and eCTD submission package (M1 to M5) compilation for final submission.
Setting up the validated publishing tool as per China eCTD requirements.
Process SOPs with process maps, quality gates and checklists.
Client internal eCTD pilot submission execution.
If you are curious
how Celegence can help with your Publishing & eCTD needs, contact us online or email us at info@celegence.com and one of our team members will get in touch with you.
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25 Mar, 2025
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