We are pleased to announce the launch of a new service, the "SOP Revision Support Service," which combines SOP analysis using the "Kenosha AI Regulatory Compliance Agent (RCA)" with the experience of our experts.

Kenosha AI, a US company with which we signed a partnership agreement late last year, offers an AI agent called Regulatory Compliance Agent (RCA). This product analyzes the impact of changes to regulatory requirements or revisions to regulations on existing SOPs and outputs the analysis results as an Excel spreadsheet. Previously, customers were responsible for revising their SOPs based on the RCA analysis results. However, in response to a request from a customer for assistance with SOP revisions, we have developed and offered this service as a packaged service that includes SOP revisions.

In this service, AI specifically tuned for regulatory compliance identifies areas to be revised, while the revisions and QC are handled by experts with years of experience in regulatory compliance, consulting, and CSV in the pharmaceutical and healthcare IT fields. Combining the speed of AI with the expertise of experienced professionals, this truly "meets the needs of our customers." We expect it to be effective in complying with ICH E6 (R3), which is now in the implementation stage, and the upcoming revisions to the new GCP Ministerial Ordinance. Details of the service will be posted on the solutions page in the future.

Kenosha AI is a solution provider that offers cloud-based AI software that allows users to search for regulatory information related to pharmaceuticals in major countries (regions) in chat format, as well as consulting on how to create effective prompts and systems for linking with internal documents. The company is headquartered in San Francisco and provides cloud-based software, customized AI, and AI consulting to a wide range of global clients.