M4Q Revision 2: Shaping the Future of Quality Submissions
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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CAPTIS® is our in-house AI-powered regulatory compliance technology, designed to streamline medical writing and documentation processes for medical device, IVD, and pharmaceutical manufacturers. With powerful automation, machine learning, and intuitive workflows, CAPTIS® performs tasks that can take hundreds of hours for regulatory teams in minutes.
CAPTIS® platform reduces manual effort, enhances regulatory accuracy, and creates effortless experiences for Celegence project teams and our customers.
62%
Average Time Savings
Compared to manual processes
45%
Faster Delivery of Full-Text PDF Search & Save
Proprietary technique for data retrieval combined with PubMed & Google Scholar Integrations
60%
Faster Literature Reviews
Average savings of 13 hours and 16 minutes with AI-powered systematic literature review module with automated data extraction
30%
Faster Clinical Evaluation Reports Delivery
Time and cost savings against manual efforts
99%
First-Time Acceptance Rate
Pre-built compliance with Health Agency & Notified Body requirements
100%
100% Article Deduplication
Users saved 100% of time because duplicates are detected automatically
Time comparison for literature search, article metadata compilation & review using manual method vs CAPTIS®.
Walk through CAPTIS® Literature Module to see how it runs a new literature search, applies filters, and performs L1 screening.
Introduction of AI into your regulatory operations brings significant efficiencies and cost savings, however, it’s important to find the right fit for it. From AI-powered turnkey deliverables to innovative transformation of compliance, we help companies leverage technology according to their needs.
Use the guide below to identify which model best matches your operational goals.
Our medical writing teams use CAPTIS® every day to efficiently manage complex regulatory workflows with AI-driven automation and consistency checks, reducing manual tasks and maintaining accuracy across all documentation.
Hear directly from CAPTIS® users about their experiences with the platform.
Medical Writer
Reviewer
Manager
Reduction of Manual Effort:
Integrations with Literature Databases, automatic capture of all article metadata upon saving a search, dedicated State of the Art workflow, automatic duplicate detection and open-access PDF downloads, integration with FDA MAUDE and TPLC Databases etc.
Traceability:
Audit trail of previous actions to ensure quicker Notified Body turnaround time
Quality & Consistency:
Templates ensure information across documentation is presented consistently; easier abbreviation and reference management
Cross-team collaboration:
commenting, simultaneous review, and ability to add sequential review workflows
More efficient content verification with source document linking
More efficient content verification with source document linking
Project Visibility & Data Control:
Regardless of how work is getting done, maintain ownership and access of project data including historical archives
Compliance:
Update templates according to Notified Body feedback and benefit from Celegence’s expert team’s knowledge
Quality:
Increase consistency across reports with data dictionary and templates
Easier Maintenance & Knowledge Management:
Centralized repository with prior versions, history and audit trail maintained in the system; making the process less people-dependent
Medical device and IVD manufacturers must meet stringent compliance demands under EU MDR and IVDR. CAPTIS® automates and accelerates compliance workflows, ensuring high-quality documentation with minimal effort.
Saves time and ensures regulatory consistency
End-to-end PMCF Survey Process
Reduces document preparation time
Consolidates results for regulatory assessments
No need for additional reference management software
Automatically updates literature insights in reports
CHIEF OPERATING OFFICER
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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.
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Data Management Specialist
Kosta is an experienced IT professional based in the Netherlands, with over 12 years of specialized expertise in managing and implementing IT solutions for the pharmaceutical industry, including business-critical applications, such as RIMS, Submission and Publishing, and DMS.
As Product Owner at Celegence, Kosta oversees the continuous development and validation of innovative proprietary software applications. He is committed to delivering high-value solutions through agile methodologies, ensuring that business requirements are effectively translated into technical solutions.
He holds a Master’s degree in Business/Managerial economics from the University of Zagreb.
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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.
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CAPTIS® consists of four specialized modules designed to streamline regulatory compliance processes:
Automates systematic literature reviews with AI data extraction, automatic PDF download, and dedicated SoTa (State-of-the-art) workflow
Captures metadata, detects duplicates, and integrates PubMed & Google Scholar searches
Integrated with FDA MAUDE, TPLC, and other databases for comprehensive adverse event tracking
Ensures traceability and real-time monitoring of regulatory concerns
Centralized repository for managing regulatory source documents, templates, and references
Ensures accuracy in CERs, PERs, and PMCF reports
GenAI-powered content generation and predefined templates to maintain consistency across reports
Review workflow made simpler & faster with source content linking, simultaneous reviews, and status dashboards
Customizable Data Collection Forms – Automatically updated summary tables reduce manual input errors
Bulk Import of Search Data – Accelerates literature review and regulatory submission processes
Dynamic Literature Review Tables – Plug directly into final report deliverables such as CERs and PMCF reports, updating in real-time
Automated Audit Trails – Ensures traceability and compliance readiness for health agencies and Notified Bodies
CAPTIS® in Action: Self-Guided Demo
Walk through CAPTIS® Literature Module to see how it runs a new literature search, applies filters, and performs L1 screening.
View Demo
Celegence partners with regulatory consulting firms, medical device manufacturers, and technology providers to enhance compliance capabilities through CAPTIS®’s AI-driven automation.
Referral access through Celegence network
Full CAPTIS® functionality with assistance from Celegence technical support team
Ensure high quality reports are developed the first time by lessening the chance of human error
100% cloud-based – allowing for fast and simple implementation
Incorporate CAPTIS®’s AI automation into existing regulatory platforms.
Enhance compliance offerings with automated document generation and AI-driven literature reviews.
Optimize MDR/IVDR documentation workflows for internal teams.
Celegence Innovation Lab brings together data scientists, AI/ML engineers, regulatory experts, and product specialists to continuously enhance CAPTIS® with the latest AI-driven automation technologies.
16 Dec, 2025
13 Nov, 2025
11 Nov, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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