CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
RIMS & xEVMPD for Global Pharmaceutical Company
Project Summary
A global biopharmaceutical company needed to streamline operations for its regulatory affairs activities, including xEVMPD submissions, document formatting, publishing and submissions to health authorities, and RIMS data collection and management.
Celegence Solution & Approach:
To achieve these objectives, the company turned to Celegence as an extension of its own internal regulatory affairs team to manage the following:
Highlights:
Establish a Center of Excellence to support end to end publishing activities like word formatting, PDF formatting, Publishing for various countries adhering to ICH standards and finalizing the submission package
Tackle document-level formatting per customer in-house specification, with Celegence using its own IT tools and processes for document and PDF publishing activities as per regulatory requirements. Find more information here: Business-Process-as-a-Service.
BPaaS platform maintenance – setup and maintenance of tools for formatting like TRS toolbox, Adobe and publishing tools.
Defining templates and QC checklist to meet ICH and country specific requirements for eCTD Publishing.
Enable robust performance monitoring and control through transparent KPI & SLA dashboards.
Project Achievements
Through its CoE working model, Celegence has delivered measurable improvements and outcomes to the biopharma client. These include:
Performance measurement through KPIs combined with budget control
Process consultancy and operational improvements for the overall program, leading to overall time reduction for operations by 50%
100% quality & timeline delivery performance despite tight timelines, an achievement that would not have been possible without Celegence’s expertise
Reduction in total cost of ownership including resources, tools and other operational cost
Improved compliance based on guidance from Celegence’s regulatory experts
Project Success
Key to the success of the partnership was the time committed to understanding the client’s goals and objectives through detailed workshops. This helped to set the tone for the project and ensure quality outcomes from the delivery team. Furthermore, having a common understanding of requirements resulted in faster turnaround time and zero errors..
Get in touch
today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.
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25 Mar, 2025
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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.
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