Request a Custom Demo
See how Celegence combines AI, automation, and expertise to make your documentation process smarter and more efficient.
Smarter Medical & Technical Writing
Consistency & Compliance Built-In
Human Expertise + AI Efficiency
Medical Device Writing Support:
CERs, PERs, SSCPs, PMCF plans and PMCF reports.
Pharma & CMC Documentation:
CMC writing, Module 3 authoring, CCDS development, and other technical content.
Structured & Compliant Outputs:
AI-enabled templates designed for MDR/IVDR and global regulatory expectations.
Data-Driven Accuracy:
Ensures consistency, clarity, and alignment across all regulatory documents.
AI-Assisted, Expert-Led:
CAPTIS® amplifies the work of Celegence’s regulatory professionals — it is not a self-serve tool.
Scientific & Compliance Control:
Writers and SMEs use automation for speed while maintaining full oversight of quality and regulatory rigor.
AI-powered regulatory services combining technology, process, and people
60% faster report turnaround with consistent, audit-ready outputs
Trusted by leading MedTech and Pharma companies worldwide
Your custom demo will be led by our senior specialists.
They’ll walk you through how Celegence integrates CAPTIS® into real-world regulatory projects to improve quality, speed, and value.
Director of Engineering
Dimitar is Director of Engineering with more than 20 years of experience in the software industry. He is a result-focused individual with great track record of success stories in his past.
He has been instrumental in the successful delivery of software solutions for wide-array of industries like automotive, advertising, education, and others.
His experience in various positions and stages of the software delivery process combined with his non-compromising attitude toward the quality of the software product helps him provide valuable client solutions.
Read More
Read Less
Technical Account Manager
Shruti Sharma is a Technical Account Manager at Celegence with a deep background in regulatory medical writing, specializing in EU MDR-compliant clinical evaluations for medical devices.
Drawing on her extensive knowledge of regulatory requirements, she translates industry needs into innovative software solutions that enhance efficiency and compliance in the Life Sciences regulatory space.
Shruti is passionate about making technology accessible and impactful, championing tech-enabled process.
Read More
Read Less
Vice President, Business Development - Medical Device
Erin brings over 20 years of experience in medical device and diagnostics, including leadership roles at Medtronic and GE Healthcare.
She has strong expertise in helping clients leverage technology and services to grow their business by solving regulatory, quality and commercial challenges.
Read More
Read Less
13 Nov, 2025
11 Nov, 2025
04 Nov, 2025
23 Oct, 2025
21 Oct, 2025
08 Oct, 2025
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
