Build ANDA Submissions with Confidence. Not Guesswork.
Regler transforms ANDA preparation into a structured, continuously evaluated, compliance-driven workflow.
Site Qualification Is Only Half the Story. You May Need ANDA
ANDA Structure Engine
Continuous Readiness Scoring
Traceability Matrix Automation
Risk & Inspection Intelligence
Multi-User Collaboration
AI Docummentation
Automated Compilation of Information
Digital ANDA Readiness Engine. Regler treats ANDA as a structured project type inside the platform.
1. ANDA Structure Engine
-
Pre-built FDA submission checklist mapping
-
Document package builder
-
Section-wise responsibility assignment
-
Auto-compilation into structured submission package
2. Continuous Readiness Scoring
-
21 CFR 314 questionnaire embedded
-
Real-time compliance scoring
-
Gap alerts before submission
3. Traceability Matrix Automation
-
URS → FS → Test → Validation evidence
-
Automatic cross-reference generation
-
Inspection-ready traceability reports
4. Risk & Inspection Intelligence
-
CFR risk frequency integration
-
FDA 483 trend alignment
-
“High exposure” areas flagged early
5. Multi-User Collaboration
-
Authors, Reviewers, Approvers
-
Role-based access control
-
Electronic signature workflow
-
Locked submission versioning
Automation and contant confirmation of quality is the priority.
-
Project Created
↓
Document Package Selected
↓
Templates Copied to Project
↓
Authors Create Sections
↓
Compliance Engine Evaluates
↓
Gaps Identified
↓
Review & Approval
↓
Final Structured ANDA Package