CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Medical Writing for a Global Pharmaceutical Company
Project Summary
Client needed medical writing support related to the authoring of their Analytical Lab Reports and Contributor Reports in compliance with the US FDA regulations, we were also tasked with finalizing and completing their backlogs of related reports.
Celegence Solution & Approach:
Celegence set up a medical writing team from both on-shore and off-shore to support these initiatives, fulfilling the required roles such as Sr. Medical Writers, QC professionals, and Subject Matter Experts.
Highlights:
Project Achievements
The entirety of the client’s backlog of reports was brought up to date and Celegence continues to author the necessary reports at the discretion of the client project manager. In partnership, we were able to accomplish the following
All pre-determined deliverable timelines were met on, or ahead of time
eCTD and QC formatting expertise led to >98% in quality of the deliverables
Client sought to extend this engagement as Celegence successfully acted as an extension of the client’s internal team
Project Success
The keys to success of the project was the proactive planning, effecting communication, and the exchange of information between all Celegence team members and the client, all working in alignment for the duration of this project that included 30+ deliverables..
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25 Mar, 2025
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