Publishing Center of Excellence in the EU, US, Japan & China for a Global Pharmaceutical CompanyCelegence2023-06-02T06:09:31+00:00
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.
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