Global Exponential Technologies (GxT
The startup develops RegWriter™, an AI-augmented authoring platform that streamlines regulatory submission workflows for medical device and biopharma professionals by standardizing templates and reducing manual effort. Their solutions address inefficiencies in regulatory affairs, clinical research, and quality management, ultimately lowering costs and improving submission quality.
- Artificial Intelligence
- Enterprise Software
- Healthcare Technology
- Software Only
Funding
Founders
Product
Problem
The creation of regulatory submissions for medical devices and biopharmaceuticals is often inefficient, relying on manual processes and inconsistent templates. This leads to increased costs, delays, and potential errors in documentation, hindering the timely approval of new products.
Solution
RegWriter™ is an AI-augmented authoring platform designed to streamline regulatory submission workflows for medical device and biopharma professionals. The platform standardizes templates and automates key aspects of the authoring process, reducing manual effort and improving efficiency. By leveraging AI, RegWriter™ helps to ensure consistency, accuracy, and compliance with regulatory requirements, ultimately lowering costs and accelerating the submission process. The platform's secure and scalable architecture allows organizations to adapt and grow while maintaining data integrity and regulatory adherence.
Target Audience
The primary target audience includes regulatory affairs professionals, clinical researchers, and quality management teams within medical device and biopharmaceutical companies.
Features
- AI-augmented authoring tools for automated content generation and review
- Standardized templates aligned with industry best practices and regulatory guidelines
- Collaborative workspace for real-time document editing and version control
- Automated categorization of post-market complaints using MDCG-recommended IMDRF Annex terminology (SmartComplaints™)
- Secure and scalable architecture to support growing organizations