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Bluenote Launches First Agentic Regulatory Platform to Accelerate Drug & Device Submissions
Resolving the $100M Submission Tax
Bluenote's specialized AI agents streamline the “Last Mile” of drug development, enabling submission teams to reduce costly delays and bring medicines and devices to patients sooner.
Bluenote, the enterprise AI platform for life sciences, today announced the general availability of its Regulatory AI Platform: the first comprehensive system built to tackle the operational complexity that delays drug and device approvals.
Every day a submission is delayed is another day patients wait for therapies they need. Across the industry, these delays compound, extending uncertainty for patients and costing companies millions in unrealized revenue. Bluenote's platform deploys specialized AI agents to compress timelines, handling the data-intensive work that has historically slowed even the most promising therapies.
Behind every approved therapy are brilliant scientists, R&D leaders, manufacturing experts, regulatory professionals, and medical writers. These are some of the most talented people in the world, working on solving the highest-stakes problems. We developed Bluenote to work the way they work: with precision, traceability, and rigor.
Closing the Gap Between Discovery and Delivery
AI-driven discovery is generating drug candidates faster than ever. However, the regulatory pipeline remains constrained. Before a company can file an Investigational New Drug (IND) Application or a New Drug Application (NDA), teams of scientists, regulatory professionals, and medical writers must navigate the "last mile" of drug development: interpreting thousands of reports, tracing facts across years of experiments, and synthesizing data spanning clinical, nonclinical, and manufacturing domains into submission-ready dossiers.
A single delayed submission extends uncertainty for patients waiting on new treatments, and leads to eight- to nine-figure losses in potential revenue.
From Data to Dossier: Intelligent Tools for Experts
For regulatory teams, the challenge isn't a lack of data. It's the operational burden of transforming that data into submission-ready documents, while maintaining the precision and traceability that regulators require. Bluenote was built to solve this problem: giving teams the ability to move from raw scientific data to polished regulatory deliverables in a fraction of the time, without sacrificing quality.
As a transplant surgeon, I watched patients wait for therapies that came too late. Now, as a CMO, I have a chance to change that. Bluenote has developed AI with the rigor and traceability that regulatory work demands, enabling the industry to move faster without sacrificing the quality patients deserve. That's a fundamental shift in what's possible.
As a transplant surgeon, I watched patients wait for therapies that came too late. Now, as a CMO, I have a chance to change that. Bluenote has developed AI with the rigor and traceability that regulatory work demands, enabling the industry to move faster without sacrificing the quality patients deserve. That's a fundamental shift in what's possible.
The platform connects directly to a company's existing data infrastructure, including ELNs, LIMS, QMS, SharePoint, Snowflake, Veeva, and other systems, enabling streamlined data ingestion and ensuring downstream documents update when sources change. Advanced extraction technology combines OCR, vision AI, and deterministic algorithms for accuracy, while sophisticated retrieval and reasoning capabilities generate regulatory deliverables. Every sentence, table cell, and derived fact links directly to its source, allowing reviewers to verify accuracy with a single click.
Four Core Capabilities for Every Stage of the Submission Process
Bluenote delivers an integrated suite of tools designed to support cross-functional teams at every stage of the submission process:
Intelligent Tools for Experts
Regulatory Authoring
Generates high-quality IND and NDA modules, from Module 1 Labeling to Module 2 Summaries and Module 5 Clinical Study Reports, by synthesizing protocols, statistical analysis plans, and TFLs. Handles complex tasks, such as generating tables that span thousands of pages, allowing experts to focus on scientific interpretation rather than compilation.
Health Authority Queries / Health Authority Responses (HAQs/RAQs)
Transforms historical regulatory data into active intelligence. Analyzes past correspondence and global health authority guidance to draft data-backed responses that are often submission-ready with minimal editing.
Intelligent Quality Control (QC)
Validates submissions against primary data, SOPs, ICH guidelines, and regulatory requirements. Performs real-time source-to-output verification, ensuring every data point matches its underlying source.
Virtual Regulator
Helps teams anticipate regulatory scrutiny before filing. Analyzes similar products and prior agency feedback to predict potential questions and identify gaps – so teams can address risks before they cause delays.
Spending over 20 years across regulatory, clinical development, preclinical, and quality roles, I have seen brilliant teams lose hours to essential, but repetitive, tasks. My passion is to clear the path, so their time can go to what matters most: helping patients and advancing science. Bluenote's advanced technology, modular approach, and intuitive interface are designed to handle the tedious, manual work, so skilled professionals can focus on strategic thinking, scientific interpretation, and regulatory expertise. Bluenote gives teams their time back to focus on what really matters: getting therapies to patients faster.
Spending over 20 years across regulatory, clinical development, preclinical, and quality roles, I have seen brilliant teams lose hours to essential, but repetitive, tasks. My passion is to clear the path, so their time can go to what matters most: helping patients and advancing science. Bluenote's advanced technology, modular approach, and intuitive interface are designed to handle the tedious, manual work, so skilled professionals can focus on strategic thinking, scientific interpretation, and regulatory expertise. Bluenote gives teams their time back to focus on what really matters: getting therapies to patients faster.
An Inflection Point for Life Sciences
The convergence of AI-powered discovery and novel therapeutic modalities is generating more promising candidates than ever before. Industry leaders see this as a turning point: a moment that demands regulatory infrastructure capable of matching the pace of scientific progress, with human-in-the-loop tools that keep experts firmly in control.
This is one of the most exciting moments in biopharma and healthcare. AI-driven discovery, novel modalities, breakthrough candidates across oncology, immunology, rare disease – the science is advancing faster than at any point in history. A moment like this demands infrastructure that can keep pace. Bluenote has built exactly that: intelligent regulatory tools with end-to-end traceability that let submissions move at the speed that science now requires.
This is one of the most exciting moments in biopharma and healthcare. AI-driven discovery, novel modalities, breakthrough candidates across oncology, immunology, rare disease – the science is advancing faster than at any point in history. A moment like this demands infrastructure that can keep pace. Bluenote has built exactly that: intelligent regulatory tools with end-to-end traceability that let submissions move at the speed that science now requires.
The next decade of medicine will be defined by how quickly we translate breakthroughs into approved therapies. There's a patient at the end of every submission, and reducing time to approval isn't just an operational goal – it's about accelerating delivery of life changing therapeutics to the patients who are waiting.
The next decade of medicine will be defined by how quickly we translate breakthroughs into approved therapies. There's a patient at the end of every submission, and reducing time to approval isn't just an operational goal – it's about accelerating delivery of life changing therapeutics to the patients who are waiting.
Availability
The Bluenote Regulatory AI Platform is available now for pharmaceutical and medical device companies. Learn more at www.bluenotehealth.com.
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