AI-powered platform for FDA risk classification, regulatory strategy, documentation, and submission
FDA Submission Copilot
Automated FDA submission
preparation and filing
preparation and filing
Generating a documentation according to the product design and the regulator's requirements for submission
Document package for FDA submission
2.Documentation
The automated submission system streamlines the process of sending your prepared documents to the FDA
Automated FDA submission
3.Submission
Analyzing intended use, and comparing similar devices to ensure accurate regulatory alignment
All possible use scenarios discovery
1.Risk classification
FDA Copilot determines the optimal regulatory pathway for your medical device, prepares all necessary documentation, and facilitates submission to the FDA. Human expert in-the-loop to double check before your submission
What we unlock
Pre-Filled Forms & Filing Instructions. Automated Filing Reminders
Standardized to avoid problems
Clear pathway
We check documentation before your submission and collaborate if the rejection is wrong
Expert in-the-loop
Submission review
Pick an option and get your legal paperwork done safely
Pay per use Pick an option
Transparent pricing
Built by experts who have already backed the regulatory process of 45 products
Clear Pricing
Guaranteed quality and 5x-20x times cheaper than traditional consultants
*Please note that these prices do not include regulatory fees and associated expenses for validation, insurance, conducting clinical trials, etc
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