AI-Powered Regulatory Guidance

Navigate FDA, MFDS Regulationswith Precision

Your comprehensive platform for FDA & MFDS regulatory intelligence. Get instant answers from our AI assistant or analyze documents for compliance gaps.

AI Regulatory Assistant

Ask Questions,
Get Cited Answers

Multi-source regulatory intelligence combining FDA/MFDS databases, guidance documents, and Warning Letter analysis. Ask complex questions and get comprehensive, CFR-cited answers in seconds.

  • FDA & MFDS integrated database search
  • Direct CFR citation support
  • Warning Letter risk analysis
  • Korean & English multilingual support
BioRegHub Chat
What are the FDA requirements for 510(k) submission?
BR

A 510(k) submission requires demonstrating substantial equivalence to a predicate device. Key requirements include:

  • Device description and intended use
  • Comparison to predicate device
  • Performance data...
Sources:21 CFR 807.87 • FDA Guidance 2023
Compliance Simulator

Overall Compliance Score

87/100
87%

Gap Analysis

Missing validation protocol signature21 CFR 820.75
Incomplete deviation documentation21 CFR 211.192
Equipment calibration records completeCompliant
Compliance Simulator

Analyze Documents,
Find Compliance Gaps

Upload regulatory documents and let AI automatically analyze compliance gaps. Get specific recommendations based on 21 CFR Part 211/820 requirements with Warning Letter risk assessment.

  • 5 document types: SOP, VP, BR, DR, CAPA
  • AI-powered requirement extraction
  • Warning Letter-based risk scoring
  • Actionable recommendations & PDF reports
FDA + MFDS
Integrated Database
5 Types
Document Analysis
211 & 820
CFR Parts Covered
AI-Powered
Risk Assessment
Get in Touch

Questions About
Regulatory Compliance?

Our team of regulatory experts is here to help you navigate FDA and MFDS requirements. Whether you have questions about our platform or need guidance on compliance challenges, we're just an email away.

Email Us

normaidlabs@gmail.com

Typically responds within 24 hours

Ready to Simplify Your
Regulatory Workflow?

Join regulatory professionals who trust BioRegHub for accurate FDA & MFDS guidance and AI-powered compliance analysis.