FDA/PMDA Expertise Delivered by Bilingual (Japanese & English) advisors!

Helping you design success in life science industry in Both US and Japan!

日米FDA/PMDA専門家！

Get In Touch

info@amenichi.com

FDA/PMDA Expertise Delivered by Bilingual (Japanese & English) advisors!

Helping you design success in life science industry in Both US and Japan!

日米FDA/PMDA専門家！

Get In Touch

info@amenichi.com

Japan/US Bridge!

Regulatory Support （規制・品質システムなど）

Amenichi offers regulatory support in many areas. Some key areas that we can support are:

Regulatory assessment and strategy
Submission assistance
FDA submissions: PreSub IDE, 510(k), CLIA, De Novo classification
Quality audits (Suppliers and Internal)
Validation
CE Marking
M&A due diligence
Warning letter remediation support

Business Development & Strategy Support 　　　（市場調査、営業サポートなど）

With strong expertise in business establishments in the US & Japan, Amenichi offers Japanese life science companies & US life science companies in many areas such as:

Business development strategies
US agent/ Initial importer
Market strategy
Product launch excellence and planning
Vendor selection strategy
Supply chain management
Portfolio review & strategy
Contract analysis
M&A strategy due diligence

Compliance Support

Amenichi supports in many areas of compliance such as:

Advertising and Promotion as a regulatory or medical reviewer
Design and implement global compliance programs
Implement compliance risk assessment
Compliance due diligence and post deal integration for M&A

FDA/PMDA Expertise Delivered by Bilingual (Japanese & English) advisors!

FDA/PMDA Expertise Delivered by Bilingual (Japanese & English) advisors!

Japan/US Bridge!

Regulatory Support （規制・品質システムなど）

Business Development & Strategy Support （市場調査、営業サポートなど）

Compliance Support

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Business Development & Strategy Support 　　　（市場調査、営業サポートなど）