Asahi Pharma Services

Asahi Kasei Corporation

Asahi Kasei Corporation is a global company operating in Materials, Homes, and Healthcare sectors. They focus on innovative chemical technology, sustainable solutions, and improving quality of life through advanced products and services.

Asahi Kasei Corporation is a diversified global company with a strong presence in the Materials, Homes, and Healthcare sectors. Leveraging advanced chemical technology and creativity, they develop environmentally friendly, high-value-added materials and solutions. In the Materials sector, Asahi Kasei offers a wide range of products including electronic devices and materials, automotive interior components, energy and infrastructure solutions like membranes and separators for batteries, and performance chemicals. They are committed to advancing environmental technology and promoting sustainability. The Healthcare sector focuses on contributing to medical therapy progress by addressing unmet medical needs with specialized leading-edge technology, enabling patients to enjoy a better quality of life. Their product offerings span various applications, from pharmaceuticals to life science materials. Asahi Kasei is dedicated to creating a better future through continuous innovation, aiming to contribute to a sustainable society by providing products and services that solve environmental and social challenges.

About

**Who they are**
Asahi Pharma Services is a division of Asahi Kasei Corporation, a global company with operations spanning Materials, Homes, and Healthcare. They leverage innovative chemical technology and sustainable solutions to enhance quality of life.

**Expertise & scope**
* Expertise in navigating the Japanese regulatory landscape for pharmaceuticals and medical devices.
* Services tailored for Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) requirements in Japan.
* Support for companies seeking to market products within Japan.

**Reputation / proof points**
* Part of the global Asahi Kasei Corporation, indicating a strong corporate backing and established presence.

Additional information

For companies looking to enter or expand their presence in the Japanese market, Asahi Pharma Services offers specialized support. Their understanding of local regulations and processes is crucial for navigating the complexities of obtaining and maintaining marketing authorization. Engagement typically involves close collaboration to ensure all regulatory requirements are met efficiently. Buyers should be prepared to provide detailed product information and documentation to facilitate the authorization process.

Key Highlights

  • Asahi Pharma Services operates within the Healthcare sector of the global Asahi Kasei Corporation. Source
    “Asahi Kasei Corporation is a global company operating in Materials, Homes, and Healthcare sectors.”
  • Provides services for the Japanese market, covering both pharmaceutical and medical device regulations. Source
    “They focus on innovative chemical technology, sustainable solutions, and improving quality of life through advanced products and services.”

Certifications & Trust Signals

  • Asahi Pharma Services is part of the established Asahi Kasei Corporation. Source
    “Asahi Kasei Corporation is a global company operating in Materials, Homes, and Healthcare sectors.”

Buyer Snapshot

Best for
  • Companies seeking MAH/DMAH services in Japan
  • International firms entering the Japanese pharmaceutical market
How engagement typically works
  • Collaborative partnership
  • Regulatory guidance and support
Typical deliverables
  • Marketing Authorization Holder services
  • Designated Marketing Authorization Holder services
  • Regulatory liaison
Good to know
  • Best when focused on the Japanese market
HQ: Kobe, JP
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: 100+
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: USD 20,000
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: No
Offers DMAH: Yes
PMDA Support: No
Local License Capability: No
Translation Support: No
GMP Qmssupport: No
Regulatory Liaison PMDA: No

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
Information regarding specific onboarding steps, required documents, or timelines is not publicly detailed.
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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