Total solution provider : eSA, Inc. from document quality to eRegulatory Submissions.
eSA provides various services through eCTD operation workflow, from environment buildup to eCTD submission.
By expenditing dossier preparation process, we always propose a best solution to support a smooth approval.
If you have any issues on electronic submission operation, we are here to help you.
We offer outsourcing service for all aspects during eCTD operation, from Word document QC, PDF editing to eCTD compilation.
eSA supports your eCTD submission.
eSA’s specialists in regulatory dossier management support eCTD submission operation in your office, when necessary and as much as required.
Our staff with profound experience proposes a solution in accordance with eCTD submission practice, also from the perspective of IT.
WordFul is the Wording eQC tool standardizing JP words usage. WordFul can help you to streamline Wording eQC processes compared to manual check by eyes.
Mi-Ke Template @QoRE-D, a MS Word-based tool, helps you create documents that support the global electronic Common Technical Document (eCTD) submission standard.
If you have any questions, please contact us from the below link. Person in charge will show you the details.
Mita43 MT. Bldg. 8F, 3-13-16 Mita, Minato-ku, Tokyo 108-0073, Japan
Tel 03-5765-2971
Fax 03-5765-2972
E-mail info@esaplus.com
We are a member of eCTD Society.
ISO/ISE 27001
