Bluenote
About Bluenote
Bluenote builds AI software that helps life sciences organizations accelerate regulatory submissions, scientific writing, and documentation workflows so therapies reach patients sooner. The platform produces review-ready drafts of regulatory and technical documents, automates repetitive, multi-step workflows with AI agents, and reduces time spent on documentation by an estimated 50–75% for customers in pharma, diagnostics, medical devices, CROs, and CDMOs.
Product & impact
Bluenote’s suite includes document generation aligned to templates and SOPs, an AI assistant for data presentation and gap analysis, workflow-building agents, searchable datasets across internal sources, and translation that preserves formatting and customer glossaries. Typical use cases cover the entire product lifecycle, from pre-clinical and clinical to CMC, regulatory, quality, and commercial activities.
- Generate first drafts of IND, NDA, BLA modules, clinical and nonclinical study reports, IBs, and RTQs
- Automate repetitive workflows with agents and workflow builder
- Search and surface institutional data and accelerate knowledge reuse
- Translate technical and regulatory documents while preserving styling and glossaries
Security & deployment
Bluenote emphasizes enterprise-grade security and compliance, including SOC 2 Type II and HIPAA controls, SAML SSO and IP allowlisting, a zero data retention policy for LLMs (no training on customer data), and options for on-premise deployment to meet strict IT and regulatory requirements.
Bluenote partners with major life sciences organizations and CROs to streamline clinical development and regulatory filing timelines, with case studies and partnerships demonstrating measurable efficiency gains.
