SERVICE

申請

We will support your application for PMDA in Japan.

・IMPD(Investigational Medicinal Product Dossier)

・eCTD (electronic Common Technical Document)

・AFM(Accreditation of Foreign Manufacturers)

DMFDrug Master File

Contents and flow of support

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Application support results

・Preparation of US Drug Master File for new biotech products (translation of Japanese into English)

・Support for conducting clinical trials of biosimilars in Japan Consulting with PMDA on quality consultation measures

・Research on introduction of biosimilars from overseas companies

・Consultation on quality consultation with PMDA 

・Master File of Biopharmaceuticals (MF) → 44 registered products (as of July 2021)

・Support for preparation of biosimilar monoclonal antibody application in Japan → Approval for manufacturing and marketing in Japan

・Support for preparation of application form for new monoclonal antibody in Japan → Manufacturing and marketing approval in Japan

・Biologics, pharmaceuticals, sterile drugs, regenerative medical products (North America, Europe, Korea, Taiwan)

・Support for preparation of biosimilar monoclonal antibody manufacturing authorization application (CTD document)

Consult with Pharmatelier about drug development

We will provide you with accurate and speedy support to solve various issues that may arise during the development and application process. Please feel free to contact us.

Consult with Pharmatelier about drug development

Consult with Pharmatelier
about drug development

We will provide you with accurate and speedy support to solve various issues that may arise during
the development and application process. Please feel free to contact us.