承認申請のための

Our experience staff perform comprehensive Gap analyses of your CMC documents in a detailed, timely manner to ensure a speedy approval process.

承認申請書及び承認申請資料の作成

We coordinate the preparation and assembly of your comprehensive regulatory submission dossier, formatted in CTD M1, M2.3, M3 and eCTD.

規制当局からの照会事項の回答

We handle all inquires regarding your application from Japanese Regulatory Authorities, providing timely responses to ensure your application is processed as quickly as possible.

軽微変更届出書及び変更登録

After your products are registered and you need to make adjustments to their application, we can handle both Minor Change Notifications and Partial Change Approval Applications on your behalf.

GMP適合性調査

Our staff can advise on GMP compliance inspections of your processes and facilities to help ensure your compliance in the most efficient way possible.

JAN

We can handle your product application for a Japanese Accepted Name (JAN) –  the official non-proprietary or generic name given to a pharmaceutical substance by the government of Japan.

外国製造業者認定

We can advise and submit your application with Japan’s PMDA for your Foreign Manufacturer Accreditation – an essential step in selling your pharmaceutical product if it is manufactured outside Japan.

MF登録

We assist and advise in all stages of your Japanese Drug Master File (DMF) Registration application.

MF国内管理人

To save you time and money establishing a company base in Japan, we can act as your In-Country Caretaker (ICC). We act as your proxy agent in Japan and take responsibility for your document preparation and submission and act as a negotiator on your behalf with Japan’s Ministry of Health and Welfare.