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 consultancy focused on navigating the complex regulatory landscape for medical devices in Japan. They leverage AI-powered solutions combined with expert human guidance to facilitate submission processes.
**Expertise & scope**
* AI-powered regulatory submission services
* Expertise in FDA 510(k), De Novo, and PMA submissions
* Streamlining regulatory processes through intelligent automation
* Guidance for medical device market entry in Japan
**Reputation / proof points**
* Coverage: Japan (JP)
Takumi Regulatory Advisors is a specialized consultancy focused on navigating the complex regulatory landscape for medical devices in Japan. They leverage AI-powered solutions combined with expert human guidance to facilitate submission processes.
**Expertise & scope**
* AI-powered regulatory submission services
* Expertise in FDA 510(k), De Novo, and PMA submissions
* Streamlining regulatory processes through intelligent automation
* Guidance for medical device market entry in Japan
**Reputation / proof points**
* Coverage: Japan (JP)
Additional information
Takumi Regulatory Advisors focuses on streamlining the submission process for medical devices, particularly for the Japanese market. Their approach integrates AI for efficiency, aiming to reduce the complexity and time associated with regulatory approvals. Buyers can expect a service that combines technological automation with expert regulatory knowledge to ensure compliance and market access.
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.
Source
“Coverage: JP”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking Japanese market entry
- Companies needing assistance with FDA submissions (510(k), De Novo, PMA)
- Organizations looking to leverage AI for regulatory efficiency
How engagement typically works
- Consultative approach
- Technology-enabled solutions
- Expert guidance
Typical deliverables
- Regulatory submission strategy
- Automated submission preparation
- Compliance guidance for Japan
Good to know
- Best when requiring specialized knowledge of Japanese medical device regulations.
- Best when seeking to optimize submission timelines through automation.
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
false
Offers DMAH
false
PMDA Support
false
Regulatory Liaison PMDA
false
Translation Support
true
