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**
* Expertise in EUDAMED Onboarding and Data Registration Support.
* Offers AI-powered regulatory services and technology solutions.
* Supports manufacturers of Pharmaceutical, Medical Device, and IVD products.
* Provides guidance on global regulatory affairs.
* Services cover regulatory landscapes in the EU and US.
**Reputation / proof points**
* Languages supported include English, French, and German.
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**
* Expertise in EUDAMED Onboarding and Data Registration Support.
* Offers AI-powered regulatory services and technology solutions.
* Supports manufacturers of Pharmaceutical, Medical Device, and IVD products.
* Provides guidance on global regulatory affairs.
* Services cover regulatory landscapes in the EU and US.
**Reputation / proof points**
* Languages supported include English, French, and German.
Additional information
For manufacturers navigating the complexities of EUDAMED, Regulatory Data EUDAMED offers a focused approach to onboarding and data registration. Their AI-powered solutions aim to streamline compliance processes, particularly for those dealing with medical devices, IVDs, and pharmaceuticals. Buyers should consider the specific EUDAMED modules they require assistance with, as the provider's specialization is in data registration and onboarding. Engagement typically involves understanding the manufacturer's product portfolio and the specific data submission requirements under the EUDAMED framework. The provider's multi-language support (English, French, German) can be a significant advantage for international clients.
Key Highlights
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Specializes in EUDAMED Onboarding & Data Registration Support.
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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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Regulatory coverage extends to the EU and US.
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“Coverage: EU, US”
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Offers services 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 seeking EUDAMED onboarding and data registration support
- Companies in the Pharmaceutical, Medical Device, and IVD sectors
How engagement typically works
- AI-powered solutions for regulatory compliance
- Specialized support for global regulatory affairs
Typical deliverables
- EUDAMED onboarding assistance
- Data registration support
- Regulatory strategy consultation
Good to know
- Best when focused on EUDAMED compliance within EU and US markets.
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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