Case Study: Eisai achieves global eCTD compliance and millions in cost savings with Adobe Acrobat

Eisai gains approval for global pharmaceutical markets

Eisai, a leading Japanese pharmaceutical company with global R&D and manufacturing operations, faced mounting costs and logistical challenges as drug approval processes generated massive volumes of paper documentation. The company needed to convert years of records into electronic Common Technical Document (eCTD)–compliant PDFs, speed global regulatory submissions, minimize human error in format checks, and create a secure platform for managing and reviewing documents.

Eisai implemented Adobe Acrobat Pro—including the Preflight validation tool, built‑in markup and audit features—and moved to an enterprise license alongside an electronic document management system, enabling a paperless workflow. The solution ensured eCTD compliance, streamlined in‑depth reviews and audit trails, reduced printing, shipping, and storage expenses, and delivered multimillion‑yen cost savings while simplifying license management company‑wide.

Eisai

Ryouichi Hiruma

Eisai Co., Ltd.