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 publishing operations for its regulatory affairs team across regions to manage significant volume with short turnaround time and to optimize the cost of operations.

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 global publishing projects for the US, EU, Japan, and China. The CoE includes skilled professionals located both onshore and offshore who are trained on the customer’s processes and tools used for Regulatory Publishing and Submissions.

This Is A Multi-year Engagement, And The Celegence Team Has Been Managing The Following Activities:

  • Word to PDF conversion and addressing requirements related to the customer-specific template, bookmarking, hyperlinking, ToC, etc., as per ICH eCTD guidelines as well as country specific requirements.

  • Electronic Quality Checks using Validation Tool as well as manual verification for documents across regions.

  • Publishing and submission activities that are region specific. Examples: Ad-Promo submissions in the US, NDA submissions in China, TSV file submissions to Japan, etc.

  • Dossier is eSubmission ready at the end of the process and handed over to the submission team.

  • Educational Walk-though Support to the customer’s authoring team  by addressing their queries related to templates, usage of specific options in IT tool as well as finalizing documents for compilation activities.

  • Formalized pilot eCTD submission project for China, National Medicinal Product Administration (NMPA), and supported in formalizing the eCTD requirements with a well-defined process, documents, and submission requirements.

  • Compilation and QC activities for various sub-processes, which are defined based on the departments authoring or owning dossiers like RA, RO, CMC, and CRO.

Center of Excellence – Key Project Achievements

This model provided flexible resourcing and efficient operational support while also allowing greater cost predictability for the client.

  • 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

  • Model provides flexible resourcing and operational support to the customer and created efficiencies and cost predictability.
  • Celegence set up global teams to support the US, Japan, and China, providing local language support in Japan and China.
  • Celegence ‘follow the sun’ resource model supporting multiple shifts and regions, gives about 18 to 20 hours of coverage to the customer.

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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