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 provides specialized AI-powered regulatory services and technology solutions focused on EUDAMED compliance and global regulatory affairs for manufacturers in the pharmaceutical, medical device, and IVD sectors.
**Expertise & scope**
* Expertise in EUDAMED onboarding and data registration.
* Support for pharmaceutical, medical device, and IVD manufacturers.
* Services encompass global regulatory affairs.
* Geographic coverage includes the EU and US markets.
* Proficiency in English, French, and German languages.
**Reputation / proof points**
* Specializes in AI-powered regulatory services and technology solutions.
Regulatory Data EUDAMED provides specialized AI-powered regulatory services and technology solutions focused on EUDAMED compliance and global regulatory affairs for manufacturers in the pharmaceutical, medical device, and IVD sectors.
**Expertise & scope**
* Expertise in EUDAMED onboarding and data registration.
* Support for pharmaceutical, medical device, and IVD manufacturers.
* Services encompass global regulatory affairs.
* Geographic coverage includes the EU and US markets.
* Proficiency in English, French, and German languages.
**Reputation / proof points**
* Specializes in AI-powered regulatory services and technology solutions.
Additional information
For manufacturers navigating the complexities of EUDAMED, Regulatory Data EUDAMED focuses on streamlining the onboarding and data registration processes. Their approach leverages AI-driven solutions to assist with compliance requirements across the EU and US. Buyers can expect support tailored to the specific needs of pharmaceutical, medical device, and IVD industries, with services available in English, French, and German.
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 pharmaceutical, medical device, and IVD manufacturers.
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“for Pharmaceutical, Medical Device, and IVD manufacturers”
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Offers services covering the EU and US markets.
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“Coverage: EU, US”
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Services are available in English, French, and German.
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“Languages: English, French, German”
Certifications & Trust Signals
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Serving clients in LU
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“Regulatory compliance expertise”
Buyer Snapshot
Best for
- Manufacturers needing EUDAMED onboarding and data registration support.
- Companies in the pharmaceutical, medical device, and IVD sectors.
How engagement typically works
- AI-powered regulatory services.
- Technology solutions for compliance.
Typical deliverables
- EUDAMED compliance strategy.
- Data registration support.
- Global regulatory affairs guidance.
Good to know
- Best when requiring support for EU and US markets.
- Best when operating in English, French, or German.
HQ:
Downers Grove, USA
Languages:
English, French, German
Timezones:
CET
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:
UDI/Devices
Submission Approach:
Portal
Managed Service Available:
Yes
Integration Support:
Access point onboarding
Additional eudamed_onboarding_support Details
Modules Supported
EUDAMED Onboarding & Data Registration
Submission Approach
Portal operations
