2025.09.01
[Important Notice] Notification of Sales and Service Termination for "uniStyle"
As a pioneer in eCTD publishing
for pharmaceutical affairs, we
will enhance our RPA processes
to further improve efficiency and
quality in global pharmaceutical
submissions.
eSA, Inc.
Introduction
eSA is a “one stop for all” and “technology backed-up” solution provider for all business related to regulatory operations in the life sciences and chemical industries, and has been widely known in the industries as a eCTD submission specialist for 19+ years in Japan.
Detail
Service
We offer the following services to support companies in the pharmaceutical and other industries that require high-quality documentation in electronic and paper media.
Detail
Products
eSA aims to provide various tools and solutions to streamline the process of creating pharmaceutical applications and compiling eCTD in the pharmaceutical industry. Our goal is to contribute to reducing the cost and time of creating high-quality approval applications.
DetaileCTD publishing
eCTD publishing
We will prepare eCTD packages for each regulatory authority. (eCTD ver4.0 compliant)
DMF
Support eCTD application and management of certificates of conformity to DMF, API Master File (ASMF), and European Pharmacopoeia Monograph (CEP).
Visit support for eCTD publishing
We offer on-site visit support to customers, tailored to their specific needs, to provide eCTD publishing services.
Consulting
We provide technical support and consulting services based on our track record and expertise to customers who are facing challenges in the eCTD application environment and publishing process.
PRODUCTS
eSA aims to provide various tools and solutions to streamline the process of creating pharmaceutical applications and compiling eCTD in the pharmaceutical industry. Our goal is to contribute to reducing the cost and time of creating high-quality approval applications.
AiX
Next-generation GenAI system for automated validation and correction of navigation items in eCTD publishing
Development of "eP2AS" series
Development of "eP2AS" series
eP2AS VAL
Check and correction system for submission-ready leaf files in eCTD publishing
eP2AS VUE
Next-generation Review and Application Management System Compatible with eCTD v4.0
CTS
Content transfer system (CTS) from protocols to CSR designed for pharmaceutical industry
DocShifter
Server-based Innovative Word-PDF File Conversion System
uniTemplate
Word template tool designed for creating pharmaceutical application documents in the pharmaceutical industry
uniStyle
Style checking tool for word documents designed for the pharmaceutical industry
uniWord
Phrase standardization tool for word documents designed for the pharmaceutical industry