Ume Quality Solutions

UMe Credit Union

UMe Credit Union is a community-focused financial institution in Burbank, CA, offering competitive rates and personalized service. As a not-for-profit credit union, earnings benefit members through higher savings rates, better loan rates, and lower fees.

UMe Credit Union, located in Burbank, California, distinguishes itself from traditional banks by prioritizing member relationships and community involvement. As a not-for-profit entity, UMe ensures that its earnings directly benefit its members, translating into more favorable savings rates, loan terms, and reduced fees. The credit union emphasizes a "WOW!" experience, aiming to exceed member expectations through personalized service and a unique, friendly approach. They foster a sense of belonging, treating members as individuals rather than just account numbers, and celebrate their distinct identity within the financial sector. UMe is deeply committed to its local community through its "UMeHelps" initiative. This program actively supports Burbank schools, local organizations, and various charitable causes through donations, volunteer efforts, and fundraising events. Members are encouraged to participate, reinforcing the credit union's philosophy of "U+Me" – working together to build a stronger community.

About

**Who they are**
Ume Quality Solutions is a provider focused on supporting companies with their regulatory compliance needs in Japan. They aim to facilitate market access and ensure adherence to Japanese regulations.

**Expertise & scope**
* Expertise in Japanese regulatory requirements for MAH/DMAH.
* Support for navigating the Japanese market.
* Services include regulatory liaison and compliance.

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

Additional information

For companies seeking to enter or operate within the Japanese market, Ume Quality Solutions offers specialized support. Their services are designed to help clients understand and comply with local regulatory frameworks, particularly concerning Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) responsibilities. Engagement typically involves close collaboration to ensure all documentation and processes meet the stringent requirements of Japanese authorities. Buyers should be prepared to provide detailed information about their products and intended market activities to facilitate effective regulatory liaison.

Key Highlights

  • Provides essential MAH/DMAH services and PMDA liaison support for foreign manufacturers entering the Japanese market. Source
    “Ume Quality Solutions provides essential MAH/DMAH services and PMDA liaison support for foreign manufacturers entering the Japanese market”
  • Specializes in Designated Marketing Authorization Holder (DMAH) services for medical device and In Vitro Diagnostic (IVD) manufacturers. Source
    “As a specialized provider of Designated Marketing Authorization Holder (DMAH) services, they serve as the essential local presence required for market entry and sustained compliance.”
  • Acts as a critical bridge for companies unfamiliar with Japan's regulatory landscape, facilitating market entry and compliance. Source
    “For companies unfamiliar with Japan's regulatory landscape, Ume Quality Solutions offers a critical bridge, acting not only as the auth”
  • Offers support for foreign manufacturers seeking to enter the Japanese market. Source
    “Ume Quality Solutions provides essential MAH/DMAH services and PMDA liaison support for foreign manufacturers entering the Japanese market”
  • Located in Osaka, Japan, providing local presence for market entry and compliance. Source
    “Location: Osaka, Japan”
  • Supports clients in Japanese, English, and Korean. Source
    “Languages: Japanese, English, Korean”

Certifications & Trust Signals

  • Experience working with regulated lifecycle documentation (seed summary)
    “Seed dataset (no public excerpt).”
  • Structured onboarding checklist and responsibility matrix approach
    “Seed dataset (no public excerpt).”
  • Multi-language coverage for cross-border teams (scope-dependent)
    “Seed dataset (no public excerpt).”

Buyer Snapshot

Best for
  • Companies seeking to establish or maintain regulatory compliance in Japan.
  • Businesses requiring support with MAH/DMAH responsibilities in the Japanese market.
How engagement typically works
  • Collaborative approach to regulatory affairs.
  • Focus on detailed documentation and process adherence.
Typical deliverables
  • Regulatory strategy advice for Japan.
  • Support with MAH/DMAH applications and filings.
  • Liaison with Japanese regulatory agencies.
Good to know
  • Best when clients have a clear understanding of their product and market strategy for Japan.
HQ: Burbank, 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: 1-5
Onboarding time: 14–60 days
Pricing model: Custom pricing
Starting from: USD 6,000
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

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 comprehensive product documentation and details regarding manufacturing processes to facilitate regulatory submissions and ongoing obligations.
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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