eSA
Boosting New Drug Applications with Powerful eCTD Submission

Electronic common technical document (eCTD) greatly aids life sciences companies in handling large volumes of critical regulatory documentation. However, emerging glitches in the submission and publishing processes make it difficult for most organizations to meet desired timelines for fulfilling the submission benchmarks of the eCTD format.

Known as the go-to eCTD partner in Japan with 19-plus years of industry experience, eSA addresses this need and ensures efficient, timely, and compliant submissions through its experienced team of regulatory affairs, operations specialists, and eCTD publishing experts.

“We specialize in supporting life sciences companies worldwide by providing customized services to meet any specific needs, whether full-service regulatory operations consulting or occasional overflow support,” says Kosuke Omoda, president of eSA.

The Japanese pharmaceutical industry is a close-knit industry with some implicit guidelines. Many foreign companies are unaware of these unspoken and unwritten parameters, making the submission of new drug applications cumbersome. eSA plays a crucial role in streamlining the submission process for these companies through its deep knowledge of guidelines in Japan and across APAC.

Typically, eCTD preparation requires compiling documents from multiple divisions like R&D, non-clinical divisions, CMC, and more. Significantly enhancing the efficiency of this process, eSA supports clients in effectively communicating with disparate divisions and acquiring the relevant documents on time. In addition, its regulatory operations services, from product registration to post-approval maintenance, are proven to ensure efficient and effective regulatory compliance across diverse client specifications.

eSA empowers the life sciences and chemical industries in Japan and beyond with its unprecedented values, leading-edge technologies, and a strong background in bridge management of global regulatory submission projects.

Through these competencies, it is emerging as a one-stop shop and technologybacked solution provider for all regulatory affairs and operationsrelated support in the life sciences and chemical industries. eSA’s key solutions include eP2AS VAL, eP2AS VUE, and Content Transcription System (CTS).

eP2AS VAL is a state-of-the-art robotic process automation (RPA) system designed to optimize eCTD publishing activities in the pharmaceutical industry. By automating tedious submission activities, this cuttingedge solution decreases roughly 70 percent of the manual workload and improves overall efficiency. Businesses can anticipate a significant decrease in eCTD publishing operating time with eP2AS VAL while maintaining higher standards.

We specialize in supporting life sciences companies worldwide by providing customized services to meet any specific needs, whether full-service regulatory operations consulting or occasional overflow support

eP2AS VUE transforms the management of eCTD packages by allowing users, from regulatory affairs officers to company representatives, to share, view, review, and manage eCTD packages from anywhere, anytime. This innovative solution incorporates comprehensive access rights control, ensuring that confidentiality is maintained. Notably, eP2AS VUE caters not only to the current eCTD v3.2.2 but also accommodates the latest v4.0 version. Essentially, it facilitates effective collaboration among regulatory affairs personnel, streamlining the entire eCTD process from initiation to completion.

At the same time, eSA’s CTS revolutionizes the process of creating the clinical study report by boosting workflows, eliminating tedious transcribing tasks, and reducing manual errors. Essentially, CTS helps regulatory affairs personnel like medical writers enhance their productivity through automated content preparation that minimizes the risk of human error and other problems.

With a talented team of regulatory experts and extensive delivery capabilities, eSA consistently delivers outstanding outcomes like increased resource scalability, quicker market entry, enhanced compliance, and consistent process excellence.

eSA continues to be a prominent player in the pharma regulatory affairs landscape opening innovative paradigms and plans to expand its service footprints to countries beyond Japan.