Are you looking for a solution to manage critical documentation easily and efficiently? Built on a robust, compliant foundation and enriched with industry-specific cutting-edge features, RegDocs365™ offers unparalleled support for life science organizations of all sizes.

Custom Content Repository
Designed specifically for life science companies, RegDocs365™ provides preconfigured folder structures for R&D, finance, legal, and more, ensuring all essential documents are organized according to regulatory body requirements, and easily accessible.

TMF and EDM Support
From clinical trials to regulatory for FDA submissions, RegDocs365™ supports Trial Master File (TMF) development and Electronic Document Management (EDM) / eCTD format, ensuring compliance and efficiency throughout the process.

Integrated AI Solutions
RegDocs365™ goes beyond basic document management with features like auto-classification, advanced search capabilities, M&A support, and integration with legacy systems for seamless data migration.

Regulatory Compliance
Fully compliant with 21 CFR 11 regulations, RegDocs365™ alleviates the regulatory burden by offering audit logging, security features, and tools for gathering regulated content from clinical sites and external contributors.

Secure Collaboration
With granular security controls, RegDocs365™ allows for sharing select information with external parties while maintaining total data governance and confidentiality. We have integrated a comprehensive security layer, ensuring your sensitive documents are always protected.

Adaptability and Expansion
Recognizing the diverse needs of life science companies, Court Square Group offers scalability and expandability. RegDocs365™ seamlessly integrates with external consulting groups to provide specialized modules, such as quality management, CMC support, and modular solutions tailored to different industry sectors.