イーサ株式会社

Total solution provider : eSA, Inc. from document quality to eRegulatory Submissions.

  • 日本語
  • English
Introduction
  • Top Page
  • About eSA
  • Services

    Introduction

    We introduce our service along the flow of the eCTD submission.
    Please see here .

    eCTD Consulting

    Consulting for eCTD development preparation, searching authorizing standard, and eCTD creation system.

    On-site Operation

    Providing adequate publishers onsite. Mitigating a risk of resource shortage on extremely busy schedule.

    Business Process Outsourcing

    Save the troubles of publisher shortage, cost, and company training. Made available at low cost.

  • Products

    Uni

    Coming Soon, As for the detailed information on this product,please click here and refer to the Japanese site

  • News
  • Contact
  • Top Page
  • Services
  • On-site Operation
  • Introduction
  • Regulatory Consulting
  • On-site Operation
  • Business Process Outsourcing
  • DMF Submission
  • お客様の声

On-site Operation is the total support services for customers want to accumulate technical know-how about eSubmission.

Flexible support on face to face

Real-time response because providing adequate publishers onsite

Coping plans for eSubmission

eSA’s specialists in regulatory dossier management support eSubmission and provide education
※Any system is acceptable

Our service is ideal for those customers:

  • Who want to mitigate a risk of resource shortage on extremely busy schedule
  • Who want to accumulate technical know-how about eSubmission in your company
  • Who need detailed responses about eQC operations and eCTD Publishing

Our service type

on_site

You can use any combination of these services.
Set the service contents after consultation with you.

QC service

Operation for Word documents
Correct and check the leaf files with eSA’s products and systems

Publishing service

Operate to PDF files
Modify and edit PDF files along eCTD requirement with eSA and partner’s products

eCTD Publishing service

Create the eCTD package
After verification, we write the eCTD package into CD-ROM/DVD-ROM as deliverable.

Scanning service

Scan paper documents in cooperation with partner

Printing service

Print and verify in cooperation with partner

Setting up service

Construct the CTD in cooperation with partner
Create labels and index as necessary

on-site_flow

Inquiry

If you have any questions about On-site Service, please contact us from the below link.
Person in charge will show you the details.

btn1

page top

eSA, Inc.

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

eCTD SocietyWe are a member of eCTD Society.BSIISO/ISE 27001

 
   
   
 
     
  • Site Map
  • Privacypolicy
  • Contact
Copyright©eSA, Inc. All rights reserved.