Project Description

Case Study: Publishing Center of Excellence in the European Union, United States, Japan, and China for a Global Pharmaceutical Company

Background – Client Needs:

A global pharmaceutical company was looking to streamline their publishing operations within their internal regulatory affairs team, including document level publishing, submission level publishing, template management, submission management, and authoring support for various global regions.

The Client Faced the Following Challenges:

  • Effective workload management for preparing and delivering regulatory submission packages for Japan, China, the EU, and the US
  • Life cycle management of previously approved products in those same regions
  • Limited resources for processing submission ready documents

Project Initiation & Key Objectives:

The client was searching for long-term partnership with a regulatory service provider for a full-service solution that required minimal oversight. The main focus of this partnership was to increase productivity and effectively manage the resources and costs while also maintaining excellent quality and risk management.

Celegence Solution & Approach:

Celegence set up a Center of Excellence (CoE) to support all of the client’s global publishing projects. The CoE involved skilled professionals located both onshore and offshore that were trained on the client’s processes and tools for Regulatory Publishing and Submission Management. This is a long term strategic engagement, and the team is currently managing the following activities:

  • Word to PDF conversions and addressing the requirements in using the client specific templates, bookmarking, hyperlinking, ToC etc., as per the ICH eCTD guidelines and country specific requirements
  • Electronic Quality Checks using the Validation Tool, as well as manual verifications
  • Publishing and Submission activities that are region specific, for example, Ad-Promo submissions in the US and NDA submissions in China

  • Ensuring dossiers are eSubmission ready at the end of the process and shared with the appropriate team responsible for the submission

  • Management of the client specific templates used for authoring documents by updating the global templates to address regional requirements and the IT software version changes

  • Supporting the authoring teams by addressing their queries related to the template usage of specific options in the IT Tool as well as finalizing documents for compilation activities

  • Participating in eCTD pilot projects related to the National Medicinal Product Administration (NMPA) and supporting the formalizing of the eCTD requirements in China
  • Performing the compilation and QC activities for various sub-processes that are defined by the teams responsible for authoring and owning dossiers like the RA, CMC and CRO teams

Center of Excellence – Key Project Achievements

This model provided flexible resourcing and efficient operational support while also allowing greater cost predictability for the client. Celegence set up global teams to support the US, EU, Japan and China regions, with local language support for latter two.

  • Defined the end-to-end process for Submission ready documents (Publishing related activities)

  • > 98% in quality of the Submission Ready Documents

  • Organized review of the Submission outputs before submitting to the Health Authorities

  • 100% turnaround timeline compliance of all activities related to the submission ready documents

  • The end-to-end approach that was defined by Celegence has resulted in significant business process improvements within the organization

  • Celegence’s highly efficient business model allowed for around the clock availability

CoE Business Impact

  • Celegence’s swift turnaround times resulted in effective lifecycle management and timely approvals and/or renewals for Japan, China, the EU, and the US markets
  • This collaborative partnership for electronic submissions had a notable impact on the costs for the client through the reduction of resources paired with high timeline compliance and quality (reduced rework)

If you’re curious how Celegence can help with your Publishing & eCTD needs, reach out to us at info@celegence.com!

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