CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Publishing Center of Excellence in the EU, US, Japan & China for a Global Pharmaceutical Company
Project Summary
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.
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
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:
Highlights:
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.
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.
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
If you’re curious
how Celegence can help with your Publishing & eCTD needs, reach out to us at info@celegence.com!
Learn MoreOther Related Articles
25 Mar, 2025
Contact Us Today
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
"*" indicates required fields