Shinrai RIM Advisors

Cruxi Inc.

Cruxi AI offers AI-powered regulatory submission services for medical devices, streamlining processes like FDA 510(k), De Novo, and PMA. They provide an intelligent platform with automated compliance checks and expert guidance.

Cruxi AI specializes in simplifying medical device regulatory submissions through an AI-powered platform. They offer 14 distinct regulatory services covering FDA and global markets, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, Humanitarian Device Exemptions (HDE), and IDE Submissions. Their platform utilizes intelligent automation, automated compliance checks, and expert guidance to streamline the entire submission process. This includes traditional 510(k) submissions with a 90-day FDA review, and support for novel, low/moderate risk devices where eSTAR use is mandatory from October 1, 2025. Cruxi AI aims to be a comprehensive solution for all regulatory needs, from device classification to the final submission package.

About

**Shinrai RIM Advisors** is a specialized consultancy focused on regulatory affairs in Japan. They offer expertise in navigating the Japanese regulatory landscape for medical devices and pharmaceuticals, acting as a crucial partner for companies seeking market access.

- **Who they are**
Shinrai RIM Advisors provides expert guidance and support for companies looking to comply with Japanese regulations, particularly for Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) services.

- **Expertise & scope**
* Support for MAH/DMAH applications and maintenance.
* Assistance with regulatory submissions to the Pharmaceuticals and Medical Devices Agency (PMDA).
* Navigation of Japanese medical device and pharmaceutical regulations.
* Translation and localization support for documentation and labeling.

- **Reputation / proof points**
* Coverage: Japan (JP)

Additional information

Engaging Shinrai RIM Advisors for Japanese market entry requires understanding their role as a local representative. They facilitate communication with regulatory bodies like PMDA and ensure that all documentation and processes adhere to Japanese standards. Buyers should be prepared to provide comprehensive product information and regulatory history to support the MAH/DMAH application process. Their services are designed to streamline the complex submission and approval pathways unique to the Japanese market.

Key Highlights

  • Specializes in Japanese regulatory affairs for medical devices and pharmaceuticals. Source
    “Shinrai RIM Advisors is a consultancy firm specializing in regulatory affairs for medical devices and pharmaceuticals in Japan.”
  • Provides support for Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) services. Source
    “We provide MAH/DMAH services for medical devices and pharmaceuticals.”
  • Offers regulatory liaison and support for the Japanese PMDA. Source
    “We support regulatory affairs for medical devices and pharmaceuticals in Japan, including liaison with the PMDA.”

Certifications & Trust Signals

  • Established presence in Japan for regulatory consulting. Source
    “Shinrai RIM Advisors is a consultancy firm specializing in regulatory affairs for medical devices and pharmaceuticals in Japan.”

Buyer Snapshot

Best for
  • Companies seeking to market medical devices or pharmaceuticals in Japan.
  • Businesses needing local representation for regulatory submissions.
How engagement typically works
  • Consultative approach to regulatory strategy.
  • Partnership for navigating PMDA requirements.
Typical deliverables
  • Regulatory strategy reports.
  • Dossier preparation and submission support.
  • MAH/DMAH consultation.
  • Compliance guidance.
Good to know
  • Best when engaging early in the product development lifecycle for Japan.
  • Requires comprehensive product and technical documentation.
HQ: Fukuoka, US
Languages: Japanese, English
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
Onboarding typically involves providing detailed product information and documentation to facilitate the regulatory submission process for MAH/DMAH services.
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
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Cruxi - Regulatory Compliance Services