
RegDocs365 is a comprehensive, 21 CFR Part 11 compliant content and document management solution designed specifically for life science companies. Built on an Audit Ready Compliant Cloud (ARCC) validated environment, it supports companies in bringing drugs, biologics, or devices to market by managing regulatory submissions. The platform streamlines workflows from discovery through commercialization, centralizing digital content including documents, data, voice, and video. RegDocs365 ensures inspection readiness with features like audit logging, granular security controls, long-term document retrieval, and OCR capabilities. It also integrates AI tools for auto-classification, advanced search, and intelligent reporting, supporting processes like Form 1572 processing and clinical site reports. The company aims to reduce IT infrastructure and financial burdens, allowing clients to focus on core activities and accelerating the path to regulatory approval.

RegDocs365 is a comprehensive, 21 CFR Part 11 compliant content and document management solution designed specifically for life science companies. Built on an Audit Ready Compliant Cloud (ARCC) validated environment, it supports companies in bringing drugs, biologics, or devices to market by managing regulatory submissions. The platform streamlines workflows from discovery through commercialization, centralizing digital content including documents, data, voice, and video. RegDocs365 ensures inspection readiness with features like audit logging, granular security controls, long-term document retrieval, and OCR capabilities. It also integrates AI tools for auto-classification, advanced search, and intelligent reporting, supporting processes like Form 1572 processing and clinical site reports. The company aims to reduce IT infrastructure and financial burdens, allowing clients to focus on core activities and accelerating the path to regulatory approval.