Eisai Co., Ltd., is one of the most well-known pharmaceutical companies in Japan. The company has global reach, with research and development laboratories, manufacturing locations, and sales offices around the world. Eisai is committed to enhancing the lives of patient and their families.
Pharmaceutical development involves a huge amount of data and documents, from reports to research materials. As new drug application workflows move towards electronic processes, Eisai saw that it must find ways to send large amounts of information quickly and reliably. Today, the company leverages electronic documents to promote communication and collaboration while improving document management and accelerating new drug application workflows by using Adobe Acrobat.
Before new drugs can be released on the market, they must be approved by authorities. It can take more than 10 years, plus countless hours and effort filling out and reviewing paperwork, to bring a single, new drug to market. Materials submitted for new drug approval processes must conform to the Common Technical Document (CTD) format as defined by the International Conference on Harmonisation (ICH). The PDF files used for electronic CTD must meet several specifications, including web optimization, bookmark settings, specific fonts, hypertext, and links.
To improve efficiency, reduce the time required to create eCTD-compatible application materials, and minimize human error, Eisai needed the ability to quickly and accurately create high-quality PDF files that conform to the specifications.
Today, Eisai uses Adobe Acrobat to create, edit, and check PDF files that meet the many conditions for materials to adhere to the eCTD format. Adobe Acrobat has built-in functions that enable teams to adjust the settings to meet specifications. In addition, the Preflight tool in Acrobat checks whether documents meet eCTD requirements.
“Adobe Acrobat is the only PDF tool with its level of sophisticated functionality, which makes it an essential part of creating materials for approval processes,” says Dr. Ryouichi Hiruma, Eisai Co., Ltd.