Regulatory Data EUDAMED
Celegence LLC
Celegence provides AI-powered regulatory services and technology solutions for Pharmaceutical, Medical Device, and IVD manufacturers, specializing in EUDAMED compliance and global regulatory affairs.
Celegence is a leading regulatory affairs service provider offering AI-empowered solutions for Pharmaceutical, Medical Device, and In-Vitro Diagnostics (IVD) customers. They specialize in navigating complex global regulations, including EUDAMED mandatory compliance for medical device and IVD manufacturers, with a particular focus on the May 28, 2026 deadline. Their services encompass the entire product lifecycle, from regulatory strategy and authoring to submission management, publishing, and health authority interaction. Celegence leverages a global team of consultants to provide local regulatory insight, strategy, and intelligence, ensuring clients achieve efficient, consistent, and compliant operations. They offer expertise in areas such as CER maintenance, CMC Module 3 documentation enhancement with GenAI, and UDI registration. Celegence is committed to delivering measurable impact in regulatory compliance, backed by certifications like ISO 9001:2015, ISO 27001:2022, and a high CSAT score. Their technology solutions include Dossplorer™ Cloud eCTD Viewer & Manager, Dosscriber™ eCTD Document Templates, and CAPTIS® AI and Automation Technology, designed to streamline regulatory processes and enhance data governance.
About
**Who they are**
Regulatory Data EUDAMED is a specialized provider of AI-powered regulatory services and technology solutions, focusing on EUDAMED compliance and global regulatory affairs for manufacturers in the pharmaceutical, medical device, and IVD sectors.
**Expertise & scope**
* EUDAMED Onboarding & Data Registration Support
* AI-powered regulatory services
* Global regulatory affairs
* Compliance solutions for Pharmaceutical, Medical Device, and IVD manufacturers
**Coverage**
* European Union (EU)
* United States (US)
Regulatory Data EUDAMED is a specialized provider of AI-powered regulatory services and technology solutions, focusing on EUDAMED compliance and global regulatory affairs for manufacturers in the pharmaceutical, medical device, and IVD sectors.
**Expertise & scope**
* EUDAMED Onboarding & Data Registration Support
* AI-powered regulatory services
* Global regulatory affairs
* Compliance solutions for Pharmaceutical, Medical Device, and IVD manufacturers
**Coverage**
* European Union (EU)
* United States (US)
Additional information
This provider focuses on streamlining the complex process of EUDAMED onboarding and data registration. Their approach leverages AI-driven technology to assist manufacturers in navigating global regulatory landscapes. Buyers can expect support tailored to the specific needs of pharmaceutical, medical device, and IVD industries, with a clear emphasis on achieving and maintaining compliance within the EU and US markets. Engagement typically involves understanding the manufacturer's product portfolio and regulatory objectives to implement effective data management and registration strategies.
Key Highlights
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Specializes in EUDAMED compliance and global regulatory affairs.
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“specializing in EUDAMED compliance and global regulatory affairs.”
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Provides AI-powered regulatory services and technology solutions.
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“Celegence provides AI-powered regulatory services and technology solutions”
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Supports manufacturers in the Pharmaceutical, Medical Device, and IVD industries.
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“for Pharmaceutical, Medical Device, and IVD manufacturers”
Certifications & Trust Signals
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Serving clients in LU
Source
“Regulatory compliance expertise”
Buyer Snapshot
Best for
- Manufacturers seeking EUDAMED onboarding and data registration support
- Companies in the pharmaceutical, medical device, and IVD sectors
- Businesses requiring assistance with global regulatory affairs
How engagement typically works
- AI-powered solutions for regulatory processes
- Specialized compliance support
Typical deliverables
- EUDAMED registration support
- Regulatory data management strategies
- Compliance guidance for EU and US markets
Good to know
- Best when requiring specialized EUDAMED expertise
HQ:
Downers Grove, USA
Languages:
English, French, German
Timezones:
CET
Claim status:
Listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU, US
Countries:
LU
Industries:
Medical Devices
Onboarding time:
7–14 days
Pricing model:
Custom pricing
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Market Surveillance
Submission Approach:
Portal, Bulk Submissions, M2M Integration
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping, Access point onboarding
Portfolio Fit:
1-5
Onboarding Speed:
1-2 weeks
Additional eudamed_onboarding_support Details
Modules Supported
EUDAMED Onboarding & Data Registration
Submission Approach
Portal operations
⚡ Instant booking available
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