Stay Submission-Ready with an AI-Powered Regulatory Check Agent

Automate checklist generation, document mapping, submission validation, and compliance review so regulatory teams can focus on filing confidence—not manual cross-checking.

Problem – The Regulatory Submission Readiness Bottleneck

Preparing FDA submissions is complex, time-sensitive, and highly manual. Regulatory, QA, and submission teams are often buried under:

Hundreds of submission requirements across FDA guidance, CFR regulations, and eCTD specifications

Manual classification, filing, and metadata entry

Large document packages that require repeated validation and review

Cross-document inconsistencies, missing references, outdated versions, and formatting issues

Late-stage compliance gaps that increase the risk of deficiency letters and submission delays

The result?

Longer submission cycles, higher review burden, missed gaps, regulatory risk, and last-minute filing pressure.

More Than Tracking — Study Start-up as an Execution System

Cloudbyz AI RegCheck Agent is a smart regulatory submission assistant that helps teams generate submission-specific checklists, map documents, validate completeness, detect inconsistencies, and maintain audit-ready evidence.
Think of it as a dedicated regulatory validation specialist that works continuously across your submission package—checking requirements, surfacing risks, and documenting every action.

Key Capabilities

AI-Powered Checklist Generation

Automatically generate submission-specific checklists for regulatory pathways such as NDA, ANDA, BLA, IND, PMA, and 510(k), with built-in citations and structured requirements.

Submission Management

Create, organize, and track submissions with real-time visibility into checklist status, document completeness, and readiness.

Document Management

Upload and manage documents with version control, bulk upload support, and centralized access.

AI-Powered Document Mapping

Automatically map documents to checklist requirements with AI-assisted suggestions and human review options.

Automated Validation Engine

Validate documents for presence, format, completeness, and compliance against regulatory requirements.

Cross-Document Verification

Identify inconsistencies, mismatches, and missing references across documents.

Document Analysis & Viewer

Review documents with highlighted evidence linked to validation results.

Review & Override System

Enable human-in-the-loop validation with full traceability of decisions.

Audit & Compliance Tracking

Maintain complete audit trails for all actions, validations, and user activities.

Reporting & Export

Generate compliance reports, validation summaries, and checklist exports.

AI Assistant

Get contextual guidance on regulatory requirements and validation outcomes.

Continuous Learning

Improve accuracy over time through feedback and user corrections.

How It Works

From Upload to Submission Readiness

Upload Documents

Upload individual files, bulk documents, or full submission packages into a structured workspace.

Generate Checklist

Select submission type and instantly create an FDA-aligned, citation-backed checklist.

Map Documents

AI automatically maps documents to checklist requirements, with options to review or adjust.

Run Validation

Validate for completeness, format, content, and cross-document consistency.

Identify Issues

View clear Pass, Fail, or Warning results with explanations and remediation guidance.

Resolve & Revalidate

Fix gaps, update documents, and re-run validation until submission-ready.

Export Reports

Generate audit-ready reports and checklist exports for final submission preparation.

Built for Regulatory & Quality Teams

Regulatory Affairs Specialists

Create checklists, manage documents, and resolve validation issues.

Quality Assurance Managers

Validate submission readiness and ensure compliance before filing.

Regulatory Affairs Directors

Track submission progress, risks, and readiness across programs.

Medical Writers

Ensure documents meet regulatory structure and content requirements.

Clinical Operations Teams

Align clinical documentation with submission expectations.

Compliance Officers

Review audit trails, validation outputs, and regulatory evidence.

Measurable Outcomes

Faster Checklist Creation

Reduce manual checklist creation from days to minutes.

Shorter Validation Cycles

Automate document review and reduce manual validation effort.

Earlier Gap Detection

Identify missing documents and inconsistencies early.

Stronger Filing Confidence

Ensure clarity on submission readiness before filing.

Audit-Ready Evidence

Maintain complete traceability across validation and decisions.

Cloudbyz AI RegCheck Agent helps teams prepare faster, validate smarter, and submit with confidence.