eSA, Inc.

Typhoon season is starting in Japan. As long as it's unnecessary, stay home or evacuate somewhere in safe.  If the load will be covered with water, go higher places possible as you can.  Check hazard map and confirm before evacuation.  River and lower land will be danger and stay out of those places.  Be safe! Reo #typhoon  

When we edit an eCTD, we must use Adobe Acrobat.   We customize it individually so that we can edit an eCTD quickly and easily. I would like to share how to customize adobe acrobat by using the toolbar. 1. Open the PDF in Adobe Acrobat. "…"at the bottom of the quick action toolbar Click the icon and select "Customize Toolbar".    2. In the "Select tools to add" section, select the tool category.     3. Expand the tool category to view the available tools and select the tool from the list. Click the "＋" icon to add the tools to the custom toolbar. the added tools will be reflected in the toolbar preview on the left side of the dialog box. 4. You can use the up and down arrows in the dialog box to rearrange the tools. Highlight the tool in the preview of the toolbar, and click the arrow to move the tool. You can also click the Add delimiter to the toolbar icon to add a delimiter to the toolbar and use the arrow to move the delimiter to the desired position. 5. Click "Save" to complete the toolbar preferences. The added tools are displayed in the quick action toolbar. Ai 😊

Hello! Today, I would like to share some tips about Adobe Acrobat. You can change the display of page numbers using Acrobat's features. Select "Page Numbers" from the dropdown menu in the Page Thumbnails panel (*1),  and then adjust the settings in the popup window as needed. (*2) The page numbers will be displayed according to the settings you configured in the popup. (*3) In the eCTD notification, the PMDA standard states, "It is easier to navigate the entire electronic document when the page numbers of the document and the PDF file are the same." It is recommended that the internal page numbering of the document matches the numbering in Acrobat.  This is also the case in the international ICH standards. Reference:   PMDA “000156705.pdf“  Page 7-4 "Page Numbering" section  https://lnkd.in/gQzfyRy3 ICH “eCTD specification 3.2.2”  Page 7-4 "Page Numbering" section https://lnkd.in/gxYUPUb3  Bye, Yuka 😉

A Glimpse into the Recent Operations Department Our department is busier than ever, and we are grateful to be experiencing a peak period. Every day, everyone is working hard, encouraging one another, and supporting each other as we tackle our tasks. Amidst this bustling activity, we are moving towards establishing a new team of part-time staff within the Operations Department. We plan to welcome new part-time members to secure additional resources and expand our team. We are looking forward to the day when we can work together with our new colleagues. If you feel a connection, why not join us at eSA? Yuka 😄

Hello everyone, Today, I would like to explain the name and logo of our company, eSA, Inc. [Image] The name "eSA, Inc." is derived from the initials of "eSubmission Automation." Now, let's delve into the meaning behind our logo. The hexagonal shape in our logo carries three significant meanings: The hexagonal honeycomb structure is known for its strength and high shock absorption, symbolizing the resilience and robustness of our company. Depending on the viewer, the hexagon can also appear as a cube, representing the diversity and multifaceted nature of our company. The hexagonal shape also pays homage to Japan's traditional technique of "Yosegi Zaiku" (parquetry), a woodworking art that combines various types of wood to create intricate patterns. This technique has a history of around 200 years. Similarly, eSA aims to bring Japan-originated systems to the global stage. We hope that our logo, imbued with these three meanings, leaves a lasting impression on you. Chihiro 😄

Hello, Today, I would like to explain the name and logo of our company, eSA, Inc. The name "eSA, Inc." is derived from the initials of "eSubmission Automation." Now, let's delve into the meaning behind our logo. The hexagonal shape in our logo carries three significant meanings: The hexagonal honeycomb structure is known for its strength and high shock absorption, symbolizing the resilience and robustness of our company.  Depending on the viewer, the hexagon can also appear as a cube, representing the diversity and multifaceted nature of our company.  The hexagonal shape also pays homage to Japan's traditional technique of "Yosegi Zaiku" (parquetry), a woodworking art that combines various types of wood to create intricate patterns. This technique has a history of around 200 years. Similarly, eSA aims to bring Japan-originated systems to the global stage. We hope that our logo, imbued with these three meanings, leaves a lasting impression on you. Michiyo 😊

In Japan, many pharmaceutical companies and DMF holders have already adopted our eCTD viewer, "eP²AS VUE." We would like to showcase the screens for Japan, the US, and Europe. Please note that the EU version is displayed in a demo environment as it has not been officially released yet. As you can see, the tree structures for the three regulatory authorities—Japan (eCTD ver 4.0), the US (eCTD ver 3.2.2), and the EU (eCTD ver 3.2.2)—are available for review. Additionally, eP²AS VUE offers robust access control settings, from the application level down to the individual leaf file level. This makes it an ideal viewer for global companies aiming to centrally manage and operate both current and historical applications. Support for eCTD version 4.0 is planned for the US by the end of 2024 and for the EU starting from 2025 onwards. We will be holding a webinar on the US eCTD version 4.0 after September, so stay tuned for the next release! Leo Related post: https://lnkd.in/ggNeQZ3f

We recently moved our office to a new building near Takanawa Gateway.  The new office is bright, stylish, has a high ceiling, and we're all pretty satisfied with it.  The new building also has a balcony and rooftop access, so we now have the office along with somewhere to take a break or have a relaxing lunch meeting.   There's even a game room in the basement with darts and billiards, so we can improve workplace relations there too!  Ai #Takanawagateway #esubmissiontokyo #newoffice 

🌟 Latest News for eCTD v4.0 🌟 The FDA has updated the Technical Conformance Guide for eCTD v4.0, aligning with the ICH eCTD v4.0 Implementation Guide and Controlled Vocabulary Package. 📄 Key updates include: 🔹 Application References to Master Files (Section 2.23) 🔹 Updated Table 2: Promotional Labeling Advertising allowable application types Stay informed and ensure compliance with these new guidelines! 📌 For more details, visit: https://lnkd.in/d3fVVaT #ectd #regulatoryaffairs #regulatoryoperations #pharmaceutical #pharmaceuticalindustry #pmda #fda #edqm #ema #publishingservices #swissmedic #tga #healthcanada #incountrycaretaker #solutions #globalregulatory #ectdpublishing

Pleased to be announced that we moved our new office at Takanawa gateway on 1st of Jun.  Thank you for participating members and whom it may concern. We look forward to working with you as we expand our business with our new office. 😀 #Takanawagateway #esubmissiontokyo #newoffice