One-stop efficiency, powered by
regulatory expertise and IT.

The transition from eCTD v3.2.2 to eCTD v4.0 for human pharmaceutical submissions is moving forward in Japan ahead of much of the world, with a mandatory deadline set for 2026. At the same time, Japan’s rapidly aging, shrinking population is expected to fall by roughly 30% over the next 50 years — raising real concerns about a shortage of regulatory affairs professionals and IT talent alike.

At founding, eSA, Inc. took over the eCTD compilation business from our predecessor, Cellec Inc., and has since provided outsourcing services and eCTD-related solutions for new drug and active substance submissions (NDA, DMF, and more) to pharmaceutical companies, CROs, and active substance manufacturers.

Our combination of regulatory expertise, an experienced team, and IT-driven one-stop solutions supports greater efficiency and quality across every stage of the submission process — authoring, validation, submission, and ongoing management.

Our IT solutions continue to evolve toward both improved usability through RPA and stronger information security. Beyond reducing operational costs and shortening submission timelines, this helps organizations run leaner in a shrinking workforce, reduce dependence on individual expertise, and stay competitive.