Freyr Solutions — Managed UDI/GUDID service
Freyr Solutions
★★★★★
4.3
/ 5
•
212 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.
**Expertise & scope**
* Specializes in UDI and GUDID solutions for FDA compliance.
* Provides regulatory support for medical devices, drug development, and more.
* Offers a unified ecosystem covering the entire regulatory lifecycle, including registrations, submissions, labeling, artwork, intelligence, and change control.
* Leverages an AI-first regulatory platform, freya fusion, driven by advanced AI/ML.
* 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.
**Expertise & scope**
* Specializes in UDI and GUDID solutions for FDA compliance.
* Provides regulatory support for medical devices, drug development, and more.
* Offers a unified ecosystem covering the entire regulatory lifecycle, including registrations, submissions, labeling, artwork, intelligence, and change control.
* Leverages an AI-first regulatory platform, freya fusion, driven by advanced AI/ML.
* 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 assists in establishing compliance processes to meet US FDA UDI requirements, offering specialized UDI and GUDID services. The Unique Device Identification (UDI) Rule, enacted by the FDA, mandates UDI requirements for medical devices to enhance traceability and patient safety. GUDID, a central FDA repository, requires detailed medical device information and UDI data submission from manufacturers. Freyr's expertise helps navigate these complex regulatory landscapes for companies marketing medical devices in the United States.
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 an AI-first regulatory platform, freya fusion, for complex compliance needs.
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”
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 needing end-to-end regulatory support for market access
How engagement typically works
- Consultative approach to regulatory challenges
- Leveraging AI-driven platform for efficiency
Typical deliverables
- UDI/GUDID compliance strategy
- Regulatory submissions support
- Lifecycle management for medical devices
Good to know
- Best when requiring specialized FDA UDI/GUDID expertise
HQ:
Princeton, USA
Languages:
English
Timezones:
UTC, EST
Claim 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
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