EU MDR compliance support for Tissue Perfusion Imaging Device
Ensuring xEVMPD Compliance for a Mid-Sized Pharmaceutical Company
Project Summary
A mid-sized pharmaceutical company partnered with Celegence to achieve compliance with the EU’s xEVMPD (extended EudraVigilance Medicinal Product Dictionary) requirements. With limited in-house expertise and increasing regulatory oversight, the client needed structured support to manage submissions, acknowledgements, and ongoing compliance monitoring. Celegence implemented a robust submission and tracking framework to ensure accuracy, transparency, and forward-looking compliance.
Challenges Faced by the Client
Ensuring timely and accurate submissions in EV Web.
Managing 3rd acknowledgement assessments to detect and resolve discrepancies.
Limited internal expertise to interpret evolving EMA requirements.
Need for consistent tracking and stakeholder reporting.
Celegence Solution & Approach:
Celegence supported the client with:
Highlights:
Managing xEVMPD submissions via EV Web with complete accuracy
Conducting detailed 3rd acknowledgement reviews and proactively resolving discrepancies
Establishing status reporting mechanisms for submission visibility and stakeholder transparency
Delivering monthly regulatory intelligence reports covering IDMP, xEVMPD, and evolving EU requirements
Project Achievements
Achieved error-free submissions with no compliance delays
Improved traceability and transparency of submission status
Delivered forward-looking regulatory insights to enable proactive planning
Strengthened the client’s confidence in consistently meeting EMA obligations
Project Success
By combining technical expertise with regulatory intelligence, Celegence enabled the client to establish a reliable, future-proof process for xEVMPD compliance. Close collaboration and proactive issue resolution ensured not only accurate submissions but also long-term confidence in EMA regulatory adherence..
Need Support with xEVMPD Compliance?
Celegence provides expert support for submissions, acknowledgements, data consistency, and ongoing EU regulatory intelligence—helping you maintain compliance with confidence. 📧 Email us at info@celegence.com
Learn MoreOther Related Articles
19 Sep, 2025
25 Aug, 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