Strategic Regulatory Consulting for Ancillary Medicinal Substances and Clinical Evidence
Saudi Food & Drug Authority (SFDA) compliance support for Laboratory Management Software Manufacturer
Project Summary
Medical writing and consulting services for creation of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in compliance with MDS-REQ-001, as required by the Saudi Food & Drug Authority (SFDA), for a Class A Software as a Medical Device (SaMD) classified under MDS-G008.
Celegence uses their proprietary CAPTIS® Platform to search for literature, write, review, and maintain the documents.
Highlights:
Draft CEP and CER for a Class A medical device in accordance with SFDA guidelines
Maintain high-quality standards through multi-level internal reviews and QA processes
Created State-of-the Art to evaluate current technologies and establish safety and performance benchmarks from similar devices
Alignment of information across all documents
Project Achievements
Enhance regulatory compliance through expert strategic guidance from Celegence
Created standardized CEP/CER template to ensure consistency, and SFDA-compliance
Continuous improvement and feedback loops for quality improvement and operational efficiency
Project Success
Key to success of this partnership is Celegence’s experienced regulatory experts working closely with the client to deliver multiple SFDA-compliant documents within tight timelines and getting approval within timeframe aligning to clients marketing strategy. .
Need SFDA-Compliant Documentation for Your SaMD?
Celegence delivers high-quality CEPs and CERs in line with SFDA requirements, supported by CAPTIS® and expert regulatory guidance—ensuring timely approvals. Email us at info@celegence.com to discuss your SFDA compliance needs.
Learn MoreOther Related Articles
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