Aoi Regulatory Solutions
Aoi Regulatory Solutions partners with BARDA to advance medical countermeasures, enhancing national health security and preparedness for public health threats.
Aoi Regulatory Solutions is a key partner in the Medical Countermeasures (MCM) initiative, working closely with BARDA (Biomedical Advanced Research and Development Authority) to enhance the nation's public health security and emergency preparedness. They facilitate communication on innovative products and solutions between federal agencies and public stakeholders, supporting the development of critical medical countermeasures from preclinical stages through FDA approval. Their involvement includes supporting BARDA's programs in advanced product development and clinical research, as well as providing flexible and innovative acquisition solutions. This collaboration aims to strengthen U.S. government contracting capabilities to respond swiftly to both known and emerging public health threats, ensuring a robust response to national health security challenges.
About
**Who they are**
Aoi Regulatory Solutions is a specialized firm dedicated to navigating the complex regulatory landscape for medical countermeasures and pharmaceuticals. They partner with organizations like BARDA to enhance national health security and preparedness.
**Expertise & scope**
* Expertise in Japanese regulatory affairs, including MAH/DMAH services.
* Support for advancing medical countermeasures.
* Focus on national health security and public health threat preparedness.
**Reputation / proof points**
* Partnership with BARDA.
Aoi Regulatory Solutions is a specialized firm dedicated to navigating the complex regulatory landscape for medical countermeasures and pharmaceuticals. They partner with organizations like BARDA to enhance national health security and preparedness.
**Expertise & scope**
* Expertise in Japanese regulatory affairs, including MAH/DMAH services.
* Support for advancing medical countermeasures.
* Focus on national health security and public health threat preparedness.
**Reputation / proof points**
* Partnership with BARDA.
Additional information
Aoi Regulatory Solutions offers specialized support for companies seeking to comply with Japanese regulations. Their services are particularly relevant for those dealing with medical countermeasures and aiming to strengthen public health preparedness. They facilitate engagement with Japanese regulatory authorities, ensuring that documentation and submissions meet local requirements. Buyers can expect a focused approach to navigating the specific nuances of the Japanese market, leveraging the provider's expertise in local compliance standards and procedures.
Key Highlights
-
Partners with BARDA to advance medical countermeasures.
Source
“Aoi Regulatory Solutions partners with BARDA to advance medical countermeasures, enhancing national health security and preparedness for public health threats.”
-
Provides regulatory support for Japan (JP).
Source
“Coverage: JP”
-
Offers services in Japanese, English, and Korean.
Source
“Languages: Japanese, English, Korean”
Certifications & Trust Signals
-
Partnership with BARDA.
Source
“Aoi Regulatory Solutions partners with BARDA to advance medical countermeasures, enhancing national health security and preparedness for public health threats.”
Buyer Snapshot
Best for
- Companies seeking to establish or maintain MAH/DMAH in Japan
- Organizations needing support with Japanese pharmaceutical and medical device regulations
How engagement typically works
- Collaborative, tailored strategy development
- Direct regulatory authority liaison
Typical deliverables
- Regulatory strategy documentation
- MAH/DMAH application support
- Compliance guidance
Good to know
- Best when focused on the Japanese market
HQ:
Yokohama, USA
Languages:
Japanese, English, Korean
Timezones:
Asia/Tokyo
Claim 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 understanding the specific product, its regulatory history, and the client's objectives within the Japanese market. This includes assessing documentation requirements for MAH/DMAH applications and planning interactions with PMDA.
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
