Project Description

Case Study: Establishing a Center of Excellence (CoE) for China eCTD Submissions

Background – Client Needs:

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.

Challenges Faced by the Client:

  • Establishing capability in regulatory publishing and eCTD submissions to China regulatory agency with dual languages: Chinese-Mandarin and English skills
  • Harmonizing the China publishing process with global process
  • Evaluating the publishing tool to be ready for China eCTD submission
  • Training on the newly established eCTD submission guidelines by China NMPA (National Medical Products Administration)
  • Operational efficiency gains related to lifecycle management of medicinal products in China region

Project Approach & Solution:

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:

  • 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.

Key Project Outcomes:

  • 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.

Business Value and Outcomes:

  • Excellent CoE business model with ready to deploy, highly skilled resources in the submission process, fluency in languages, and underlying technology understanding
  • Well-established ready to use, an end-to-end business process for China eCTD submission much before expected go-live – this model can also be leveraged for other types of submissions for China
  • Established new capabilities within 6 months, with minimal/no impact to existing business processes and functional stakeholders
  • Software tool vendor management, oversight, and maintenance of validated solution by Celegence
  • Enhancement of regulatory and process knowledge of the business team

  • Managed services and delivery model with a combination of nearshore and offshore workforce

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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