Kawa RIM Partners
Yaskawa America, Inc. - Drives & Motion Division
Yaskawa America is a leading global manufacturer of variable frequency drives, servo systems, machine controllers, and industrial robots, known for outstanding quality and reliability.
Yaskawa America, Inc. is a prominent global leader in the manufacturing of variable frequency drives, servo systems, machine controllers, and industrial robots. Their products, whether standard offerings or custom solutions, are highly regarded for exceptional quality and unwavering reliability. The company serves various industries, providing advanced solutions for machine performance and control. Yaskawa America is committed to innovation, as demonstrated by their latest offerings like the Sigma-X servo system, designed to elevate machine performance. They also provide comprehensive pumping solutions for diverse applications. With a strong presence and a focus on customer support, Yaskawa America is a trusted partner for businesses seeking cutting-edge automation and motion control technology.
About
**Who they are**
Kawa RIM Partners is a specialized firm focused on supporting companies navigating the Japanese regulatory landscape for pharmaceuticals and medical devices. They act as a crucial link for foreign entities seeking to market their products in Japan.
**Expertise & scope**
* Expertise in Japanese regulatory affairs, including MAH/DMAH services.
* Support for interactions with the PMDA (Pharmaceuticals and Medical Devices Agency).
* Services encompass regulatory liaison and documentation.
* Multilingual support in Japanese, English, Chinese, and Korean.
**Reputation / proof points**
* Coverage limited to Japan (JP).
Kawa RIM Partners is a specialized firm focused on supporting companies navigating the Japanese regulatory landscape for pharmaceuticals and medical devices. They act as a crucial link for foreign entities seeking to market their products in Japan.
**Expertise & scope**
* Expertise in Japanese regulatory affairs, including MAH/DMAH services.
* Support for interactions with the PMDA (Pharmaceuticals and Medical Devices Agency).
* Services encompass regulatory liaison and documentation.
* Multilingual support in Japanese, English, Chinese, and Korean.
**Reputation / proof points**
* Coverage limited to Japan (JP).
Additional information
Engaging Kawa RIM Partners requires a clear understanding of the Japanese market's specific regulatory pathways. Buyers should prepare detailed product information and regulatory histories for efficient onboarding. The firm's multilingual capabilities are a significant asset for clear communication throughout the submission and approval processes. Given the reliance on provider-uploaded documents, direct engagement for clarification on specific service nuances is recommended.
Key Highlights
- Expert MAH/DMAH services tailored for foreign medical device and IVD manufacturers targeting Japan Source
- Dedicated PMDA liaison and comprehensive communication management for Japanese regulatory compliance Source
- End-to-end support for product lifecycle management and ongoing regulatory obligations in Japan Source
- Specialized expertise in clearly defining and managing distinct responsibilities between local license holders and international companies Source
- Proficient in preparing all necessary regulatory filings and managing essential documentation for market entry and maintenance Source
Certifications & Trust Signals
- Provides a structured operational escalation path for addressing urgent regulatory deadlines and inquiries Source
- Possesses documented experience in managing and coordinating regulated product lifecycle documentation Source
- Offers support for maintaining regulatory standing through change assessments and structured escalation processes Source
Buyer Snapshot
Best for
- Companies seeking to enter the Japanese market with pharmaceuticals or medical devices.
- Entities requiring a local representative for regulatory submissions.
How engagement typically works
- Requires detailed product and regulatory documentation.
- Communication facilitated by multilingual staff.
Typical deliverables
- MAH/DMAH services.
- Regulatory liaison with PMDA.
- Documentation support for Japanese market entry.
Good to know
- Best when focused on the Japanese market.
HQ:
Waukegan, US
Languages:
Japanese, English, Chinese, Korean
Timezones:
Asia/Tokyo
Status:
listed
Services & Capabilities
Japan MAH / DMAH Services
Jurisdictions:
JP
Countries:
JP
Industries:
Medical devices, IVD, Life sciences
Portfolio:
6-25
Onboarding time:
10–45 days
Pricing model:
Per project
Starting from:
USD 8,500
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
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 detailed product information and regulatory histories for efficient onboarding.
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
