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 provides AI-powered regulatory submission services for medical devices.
**Expertise & scope**
* Streamlining regulatory submissions through intelligent automation and expert guidance.
* Specializing in medical device regulatory pathways including FDA 510(k), De Novo, and PMA.
* Coverage for Japan (JP).
* Services available in Japanese, English, and Korean.
**Reputation / proof points**
* AI-powered submission services.
Takumi Regulatory Advisors provides AI-powered regulatory submission services for medical devices.
**Expertise & scope**
* Streamlining regulatory submissions through intelligent automation and expert guidance.
* Specializing in medical device regulatory pathways including FDA 510(k), De Novo, and PMA.
* Coverage for Japan (JP).
* Services available in Japanese, English, and Korean.
**Reputation / proof points**
* AI-powered submission services.
Additional information
Takumi Regulatory Advisors focuses on leveraging AI for efficient medical device regulatory submissions. Their approach aims to simplify complex processes like FDA 510(k), De Novo, and PMA applications. The firm provides support for the Japanese market, with capabilities in Japanese, English, and Korean, facilitating smoother communication and documentation for a diverse client base.
Key Highlights
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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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Expertise in FDA 510(k), De Novo, and PMA submissions.
Source
“including FDA 510(k), De Novo, and PMA.”
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Regulatory coverage for Japan (JP).
Source
“Coverage: JP”
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Multilingual support including Japanese, English, and Korean.
Source
“Languages: Japanese, English, Korean”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device companies seeking streamlined regulatory submissions.
- Firms requiring support for FDA 510(k), De Novo, and PMA pathways.
- Companies needing regulatory expertise for the Japanese market.
How engagement typically works
- AI-driven automation for submission processes.
- Expert guidance throughout the regulatory lifecycle.
Typical deliverables
- Regulatory submission strategy and execution.
- Automated submission documentation.
- Liaison for Japanese regulatory authorities.
Good to know
- Best when requiring specialized support for medical device regulations in Japan and the US.
HQ:
Fukuoka, US
Languages:
Japanese, English, Korean
Timezones:
Asia/Tokyo
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
Intake → scope & product mapping → mandate & responsibility matrix → workflow setup → PMDA liaison cadence
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
