Tsuru Liaison Gateway
Cruxi Inc.
Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks for global markets.
Cruxi provides a comprehensive AI-powered regulatory platform designed to simplify medical device submissions. Their services cover the entire regulatory process, from device classification to final submission packages, for both FDA and global markets. Leveraging intelligent automation and expert guidance, Cruxi aims to streamline submissions for various pathways, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. The platform offers 14 distinct regulatory services, encompassing automated compliance checks and repeatable templates to ensure efficiency and accuracy. Cruxi is particularly noted for its support in navigating complex submissions like the De Novo Classification Request, which mandates eSTAR use from October 1, 2025. They also assist with formal device classification determinations and real-time supplements, providing a one-stop solution for all regulatory needs.
About
**Who they are**
Tsuru Liaison Gateway is a specialized provider focused on navigating the Japanese regulatory landscape for medical devices and pharmaceuticals. They act as a crucial link between international companies and Japanese authorities.
**Expertise & scope**
* Facilitating regulatory submissions within Japan.
* Providing expert guidance on compliance requirements for the Japanese market.
* Offering support for global regulatory strategies with a focus on Japan.
**Reputation / proof points**
* Coverage includes Japan (JP).
Tsuru Liaison Gateway is a specialized provider focused on navigating the Japanese regulatory landscape for medical devices and pharmaceuticals. They act as a crucial link between international companies and Japanese authorities.
**Expertise & scope**
* Facilitating regulatory submissions within Japan.
* Providing expert guidance on compliance requirements for the Japanese market.
* Offering support for global regulatory strategies with a focus on Japan.
**Reputation / proof points**
* Coverage includes Japan (JP).
Additional information
Companies engaging with Tsuru Liaison Gateway can expect a dedicated focus on the intricacies of the Japanese market. Their services are designed to streamline the often complex process of obtaining authorization for medical devices and pharmaceuticals. Engagement typically involves close collaboration to ensure all documentation and submission requirements are met according to Japanese regulatory standards. Buyers should be prepared to provide detailed product information and regulatory history to facilitate the process.
Key Highlights
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Specializes in medical device regulatory submissions, including FDA 510(k), De Novo, and PMA.
Source
“Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA.”
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Provides expert guidance and automated compliance checks for global markets.
Source
“They provide expert guidance and automated compliance checks for global markets.”
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Offers coverage for Japan (JP).
Source
“Coverage: JP”
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Supports multiple languages including Japanese, English, and Korean.
Source
“Languages: Japanese, English, Korean”
Certifications & Trust Signals
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Focuses on regulatory submissions for global markets.
Source
“Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks for global markets.”
Buyer Snapshot
Best for
- Companies seeking to establish MAH/DMAH status in Japan
- International firms needing local regulatory representation in Japan
- Medical device and pharmaceutical manufacturers entering the Japanese market
How engagement typically works
- Local liaison and representation
- Regulatory guidance and support
- Facilitation of PMDA interactions
Typical deliverables
- MAH/DMAH application support
- Regulatory strategy consultation for Japan
- Communication channel with Japanese authorities
Good to know
- Best when focused on the Japanese market entry and compliance
HQ:
Nagoya, US
Languages:
Japanese, English, Korean
Timezones:
Asia/Tokyo
Claim status:
Listed
Services & Capabilities
Japan MAH / DMAH Services
Jurisdictions:
JP
Countries:
JP
Industries:
Medical devices, IVD, Life sciences
Portfolio:
1-5
Onboarding time:
14–60 days
Pricing model:
Custom pricing
Starting from:
USD 6,000
Included services:
MAH/DMAH appointment support, PMDA liaison and communications routing, Local license/establishment maintenance support, Translation enablement (scope-dependent), GMP/QMS coordination support (scope-dependent)
Offers MAH:
Yes
Offers DMAH:
Yes
PMDA Support:
Yes
Languages:
Japanese
Local License Capability:
Yes
Translation Support:
Yes
GMP Qmssupport:
Yes
Regulatory Liaison PMDA:
Yes
Additional jp_mah_dmah Details
Included Services Detailed
MAH/DMAH onboarding and mandate setup (seed scope), PMDA liaison and communications routing (seed scope), Local license/establishment maintenance tasks (seed scope), Translation enablement for core regulatory documents (seed scope), GMP/QMS coordination support for audit readiness (seed scope)
Excluded Services
Manufacturing or supply chain execution, Acting as commercial distributor by default, Legal representation in disputes or litigation
Onboarding Steps
Requires comprehensive documentation regarding the device's design, manufacturing, and pre-clinical/clinical data.
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
Yes
Offers DMAH
Yes
PMDA Support
Yes
Regulatory Liaison PMDA
Yes
Translation Support
Yes
