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:
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.
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)