Takumi Regulatory Advisors
Takumi Regulatory Advisors offers AI-powered regulatory submission services for medical devices, including FDA 510(k), De Novo, and PMA. They streamline the process with intelligent automation and expert guidance.
Takumi Regulatory Advisors provides comprehensive regulatory submission services for medical devices, leveraging AI-powered workflows and expert guidance. Their platform covers a range of FDA submissions, including 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. They aim to streamline the entire process from device classification to the final submission package, offering automated compliance checks and intelligent automation. With 14 services covering both FDA and global markets, Takumi Regulatory Advisors positions itself as a single, intelligent platform for all regulatory needs. They offer specialized workflows for traditional 510(k) submissions, which typically have a 90-day FDA review period. For novel, low to moderate-risk devices, they support the eSTAR format, which will be mandatory from October 1, 2025. Additionally, they assist with formal device classification determinations and 180-day Real-Time supplements. Their services are designed to simplify complex regulatory pathways, ensuring that clients receive expert support at every step. The focus on AI and automation aims to increase efficiency and accuracy in regulatory submissions, making the process more manageable for medical device companies.
About
**Who they are**
Takumi Regulatory Advisors is a specialized firm providing AI-powered regulatory submission services for medical devices. They focus on streamlining the complex submission process for global markets.
**Expertise & scope**
* AI-powered regulatory submission services
* Expert guidance for medical device submissions
* Streamlining submission processes through intelligent automation
* Specialized knowledge in FDA 510(k), De Novo, and PMA submissions
* Coverage for Japan (JP)
**Reputation / proof points**
* Languages supported: Japanese, English, Korean
Takumi Regulatory Advisors is a specialized firm providing AI-powered regulatory submission services for medical devices. They focus on streamlining the complex submission process for global markets.
**Expertise & scope**
* AI-powered regulatory submission services
* Expert guidance for medical device submissions
* Streamlining submission processes through intelligent automation
* Specialized knowledge in FDA 510(k), De Novo, and PMA submissions
* Coverage for Japan (JP)
**Reputation / proof points**
* Languages supported: Japanese, English, Korean
Additional information
Takumi Regulatory Advisors leverages artificial intelligence to enhance the efficiency and accuracy of medical device regulatory submissions. Their approach combines automated tools with expert human oversight, aiming to reduce the time and complexity typically associated with navigating regulatory pathways like FDA 510(k), De Novo, and PMA. For clients targeting the Japanese market, they offer support in Japanese and English, ensuring clear communication and adherence to local requirements.
Key Highlights
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Offers AI-powered regulatory submission services for medical devices.
Source
“Takumi Regulatory Advisors offers AI-powered regulatory submission services for medical devices”
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Specializes in FDA 510(k), De Novo, and PMA submissions.
Source
“including FDA 510(k), De Novo, and PMA.”
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Provides regulatory support for the Japanese market (JP).
Source
“Coverage: JP”
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Supports multiple languages including Japanese, English, and Korean.
Source
“Languages: Japanese, English, Korean”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking streamlined regulatory submissions.
- Companies needing assistance with FDA 510(k), De Novo, and PMA pathways.
- Providers targeting the Japanese market.
How engagement typically works
- AI-assisted process automation.
- Expert guidance and consultation.
- Multilingual support (Japanese, English, Korean).
Typical deliverables
- Completed regulatory submission packages.
- Streamlined submission workflows.
- Guidance on navigating regulatory requirements.
Good to know
- Best when requiring specialized support for complex FDA submissions.
- Best when targeting the Japanese market.
HQ:
Fukuoka, 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:
26-100
Onboarding time:
7–30 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 12,000
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
The provided information does not detail specific onboarding steps, required documents, timelines, or setup procedures.
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
No
Offers DMAH
No
PMDA Support
No
Regulatory Liaison PMDA
No
Translation Support
Yes
