Bluenote provides AI agents and workflow automation specifically designed for the life sciences industry to accelerate regulatory submissions. The platform automates document generation, data presentation, and multi-step workflows across the entire product lifecycle, from pre-clinical to commercial stages. It ensures enterprise-grade security and compliance while allowing organizations to focus scientific resources on innovation rather than administrative tasks.
Funding
$10M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.


Founders
Product
Problem
Life sciences companies face significant time and resource burdens in preparing regulatory and compliance documentation, such as Clinical Study Reports and Informed Consent Forms. The manual processes of copy-pasting, synthesizing information, and ensuring accuracy across documents are time-consuming and can delay the submission process.
Solution
Bluenote provides an AI platform designed to automate the creation and enhancement of regulatory documents for life sciences companies. The platform streamlines workflows by automating copy-pasting and synthesis tasks, improving document quality and accelerating the regulatory submission timeline. By leveraging AI, Bluenote ensures accuracy and verifiability of AI outputs by using factual details from traceable primary sources, combining guardrails with custom Large Language Models (LLMs), and inserting call-to-action placeholders for human review. The platform supports various applications, including regulatory filings, technical reports, protocols, Standard Operating Procedures (SOPs), validation reports, risk analyses, and manufacturing documentation.
Target Audience
The primary target audience includes scientists, engineers, and regulatory professionals within life sciences companies who are responsible for producing regulatory filings, technical reports, and other compliance documentation.
Features
- AI-powered automation of document synthesis and formatting for CSRs, CMC documents, AV reports, ICFs, and more
- Optimized Retrieval-Augmented Generation (RAG) that ingests data from various data lakes and third-party applications
- Multi-model approach combining the best models from Anthropic, OpenAI, Google, and fine-tuned proprietary models
- Customizable outputs via proprietary datasets and connectivity to data lakes
- Workflow optimized for life sciences datasets, delivering accuracy through tailored data pipelines
- Agentic workflow orchestrating hundreds of LLM calls and algorithms
- Secure platform engineered to meet robust security standards, such as HIPAA, GDPR, SOC2, CLIA, and CAP
- Strict data policy ensuring data is not used to train models, with zero data retention policy with LLMs