Bluenote
About Bluenote
Bluenote is a company focused on accelerating regulatory submissions in life sciences by 50-75% through the use of advanced AI technology. Their platform is trusted by the industry's largest pharma, medical devices, diagnostics companies, CROs, and CDMOs.
Mission and Solutions
Bluenote aims to bring life-saving therapies to patients sooner by automating critical workflows in scientific and regulatory document generation. Their AI-driven platform offers multiple features including document generation aligned to templates, AI assistant for refining data presentations, AI agents for automating repetitive workflows, dataset search capabilities, and translation of technical regulatory and marketing documents. Bluenote integrates with various data sources like ELN, QMS/DMS, data warehouses, and data lakes to ensure 100% traceability and accuracy.
The platform is designed for enterprise scalability and ease of use with no steep learning curves, allowing faster adoption and value delivery from day one. It supports documentation across all stages of development including pre-clinical, clinical, CMC, regulatory, quality, and commercial phases, helping extend automation throughout the product lifecycle.
Security and compliance are key aspects, with adherence to SOC 2 Type II and HIPAA standards, enterprise-grade features like SAML SSO, IP allowlisting, and options for on-premise deployment to maximize security and control.