Freyr Solutions — Managed UDI/GUDID service
Freyr Solutions
★★★★★
4.3
/ 5
•
211 reviews
Freyr Solutions is a global regulatory solutions and services company specializing in UDI/GUDID services for FDA compliance. They offer end-to-end regulatory support for medical devices, drug development, and more.
Freyr Solutions is a global regulatory solutions and services provider with over 15 years of expertise. They offer comprehensive support for regulatory compliance across various industries, including pharmaceuticals and medical devices. Their services encompass UDI and GUDID solutions for FDA compliance, drug development, regulatory strategy, dossier authoring, post-approval lifecycle management, and country-specific regulatory services. Leveraging their AI-first regulatory platform, 'freya fusion,' Freyr assists businesses in navigating complex compliance needs throughout the entire regulatory lifecycle. They have a strong presence in over 150 countries and expertise in more than 16 therapeutic areas. Freyr is recognized for its ability to transform regulatory intelligence processes and deliver real regulatory wins, turning compliance into success for their clients. With strategically located offices worldwide, including in the United States, Freyr provides specialized UDI and GUDID services to help medical device manufacturers meet US FDA requirements. They offer expert guidance on UDI implementation, GUDID database submissions, and ensure accurate data management for device traceability and patient safety.
About
**Who they are**
Freyr Solutions — Managed UDI/GUDID service is a global regulatory solutions and services company with over 15 years of experience, specializing in UDI/GUDID services for FDA compliance. They offer end-to-end regulatory support for medical devices, drug development, and more.
**Expertise & scope**
* Specializes in UDI and GUDID solutions for FDA compliance, including understanding the Unique Device Identification (UDI) Rule and the Global Unique Device Identification Database (GUDID).
* Provides regulatory support for medical devices, drug development, and other product types seeking market access.
* Offers a unified regulatory platform, freya fusion, powered by AI/ML, covering the entire regulatory lifecycle from registrations and submissions to labeling and change control.
* Has an in-house office in the United States with medical device regulatory experts.
**Reputation / proof points**
* Grounded in 15+ years of regulatory expertise.
* Strategically located across regions including the Americas, Europe, Asia-Pacific, Africa, and the Middle East.
Freyr Solutions — Managed UDI/GUDID service is a global regulatory solutions and services company with over 15 years of experience, specializing in UDI/GUDID services for FDA compliance. They offer end-to-end regulatory support for medical devices, drug development, and more.
**Expertise & scope**
* Specializes in UDI and GUDID solutions for FDA compliance, including understanding the Unique Device Identification (UDI) Rule and the Global Unique Device Identification Database (GUDID).
* Provides regulatory support for medical devices, drug development, and other product types seeking market access.
* Offers a unified regulatory platform, freya fusion, powered by AI/ML, covering the entire regulatory lifecycle from registrations and submissions to labeling and change control.
* Has an in-house office in the United States with medical device regulatory experts.
**Reputation / proof points**
* Grounded in 15+ years of regulatory expertise.
* Strategically located across regions including the Americas, Europe, Asia-Pacific, Africa, and the Middle East.
Additional information
Freyr Solutions emphasizes a comprehensive approach to regulatory compliance, particularly for medical devices entering the US market. Their freya fusion platform is highlighted as an AI-first solution designed to manage complex compliance needs throughout the product lifecycle. For UDI/GUDID compliance, they leverage their US-based regulatory experts to assist manufacturers in establishing necessary processes. Buyers can engage with Freyr for end-to-end regulatory solutions, from initial strategy and dossier authoring to post-approval lifecycle management, ensuring market access for innovative products.
Key Highlights
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Specializes in UDI and GUDID solutions for FDA compliance.
Source
“UDI and GUDID Solutions for the FDA Compliance”
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Offers freya fusion, an AI-first regulatory platform covering the entire regulatory lifecycle.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”
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Possesses over 15 years of regulatory expertise.
Source
“Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML.”
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Has an in-house office in the United States with medical device regulatory experts.
Source
“Freyr has an in-house office in the United States with medical device Regulatory experts and resources”
Certifications & Trust Signals
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Global presence with offices across Americas, Europe, Asia-Pacific, Africa, and Middle East.
Source
“We are strategically located across regions like the Americas, Europe, Asia-Pacific, Africa, and Middle East.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA UDI/GUDID compliance
- Companies requiring end-to-end regulatory support for market access
- Organizations looking for AI-driven regulatory platforms
How engagement typically works
- Consultative support for regulatory strategy
- Platform-based solutions (freya fusion)
- Project-based assistance for specific compliance needs
Typical deliverables
- UDI/GUDID compliance strategy and implementation
- Regulatory submissions and registrations
- Lifecycle management support
- AI-powered regulatory intelligence
Good to know
- Best when engaging for complex, global regulatory challenges.
HQ:
Princeton, USA
Languages:
English
Timezones:
UTC, EST
Status:
listed
Services & Capabilities
FDA GUDID Submission Tools
Pricing model:
Custom pricing
Submission Route:
managed_service
Generates Spl:
No
Handles Esgsubmission:
Yes
Validation Tools:
No
Gdsn Integration:
No
Additional gudid_submission_tools Details
Submission Route
managed_service
Generates Spl
No
Handles Esgsubmission
No
Validation Tools
No
Gdsn Integration
No
