Product Overview
RegDocs365™ – The Platform for Life Science Content Management
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.
Deployment
- Web based
- Cloud Hosted
Pricing
- License Fee
- Price per Trial sites
More Information
Basic Capabilities
- Qualified Microsoft based infrastructure including SharePoint and SQL Server
- Content management system preconfigured to EDM Reference Model for regulatory submissions and Electronic Trial Master File (eTMF)
- Submission-ready PDF renditions
- Collaborative review and approval workflows
Advanced Capabilities
- Configured for Trial MasterFile Reference Model (eTMF)
- Submission management for IND, MDF, ANDA, NDS, BLA Submissions
- Optional submission templates for eCTD document authoring
- Optional eCTD publishing services and software
About the company
RegDocs365 came about as a result of the collaboration between Court Square Group hosting a submission processing environment for eSubmissionSolutions. The founders, Keith Parent from Court Square Group and Antoinette Azevedo from eSubmissionSolutions had been working together for a number of years. Recognizing the significance of the environment that Antoinette was using for her client base we decided that this would be a great offering for small to mid-size companies looking to do their own Regulatory filings. By replicating the environment for other Regulatory customers we were able to have our first regulatory offerings featuring the DIA EDM and eTMF reference model.