Quantum IND
Your fastest path to first-in-human
We help sponsors build submission-ready INDs twice as fast and at a fraction of the cost, starting with intelligent pre-clinical design powered by expert strategy and AI precision.
Command Center
On schedule
Average review completion
+2% above industry average
CMC Section Review Required
IND-2024-03
FDA Response Due
IND-2024-01
Safety Update
15 items need review
Pre-IND Meeting
Completed - Jan 15, 2024
IND Preparation
In Progress - Due Mar 1, 2024
FDA Submission
Upcoming - Mar 15, 2024
How it Works
Our streamlined approach combines expert guidance with AI-powered tools to accelerate your IND submission process
Preclinical Strategy & Design
We begin with smart study design—guided by your molecule's biology, therapeutic goals, and regulatory path. Our team uses predictive simulations and AI tools to identify optimal animal models, dosing strategies, and timelines.
Preclinical Study Execution
We partner with top-tier labs to run your studies, prioritized to meet your IND timelines. Our team manages execution end-to-end, while our proprietary AI tools and organoid simulations help fill gaps, accelerate data generation, and align with FDA expectations for emerging modalities.
Regulatory Engagement
We lead your Pre-IND meeting strategy, ensuring your briefing package highlights what matters and avoids common red flags. Former FDA reviewers help you ask the right questions, frame your program strategically, and de-risk the path to “Safe to Proceed.”
IND Module Development
From CMC to nonclinical to clinical protocols, each IND section is developed by regulatory experts and accelerated with AI-powered drafting, QC, and formatting. We engage trial sites early to streamline investigator selection and phase 1 design. A centralized operating system tracks all documents and dependencies, making it easy to stay aligned and quickly adapt as new data emerges.
Submission Readiness & Filing
We prepare your IND for submission, managing publishing, formatting, and final QC. Whether we file directly or support your team, you'll have a complete, defensible submission that's on time and ready for review.
Ongoing Support
Post-submission, we monitor correspondence, prepare responses, and help you get to “Safe to Proceed” faster. We're with you through clinical trial kickoff and beyond.
A Platform built for hybrid intelligence
Combining cutting-edge AI with deep regulatory expertise to transform how INDs are prepared, reviewed, and submitted
AI-Powered Document Generation
Our platform uses advanced AI to draft, review, and optimize regulatory documents, cutting preparation time by up to 70%.
Expert Review System
Every AI-generated document is reviewed by former FDA reviewers and regulatory experts to ensure compliance and strategic positioning.
Predictive Analytics
Leverage data from thousands of successful submissions to predict review timelines, identify potential issues, and optimize your IND strategy.
Collaborative Workspace
A secure, centralized platform where your team and our experts can collaborate in real-time on all aspects of your IND submission.
Automated Quality Control
Our system automatically checks for consistency, completeness, and compliance across all IND modules, flagging potential issues before submission.
Regulatory Intelligence
Stay current with the latest FDA guidance and precedents relevant to your specific therapeutic area and development program.
Ready to accelerate your IND submission?
Schedule a consultation with our regulatory experts to discover how Quantum IND can help you reach first-in-human trials faster and more efficiently.