72 Billion dollars by 2021.

That’s the projected size of the Japanese Pharmaceutical Market.
Will your products be part of it?

Our Services include:

GAP Analysis

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

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Regulatory Dossier

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

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Regulatory Inquiries

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

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Change Application Submission

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.

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GMP Compliance

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

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JAN – Japanese Accepted Name

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.

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Foreign Manufacturer Accreditation

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.

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DMF Registration

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

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In Country Caretaker

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.

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Let’s Launch Your Product

NAVIGATING JAPAN’S REGULATIONS IS HARD. LET US HELP YOU GET APPROVAL.

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