ANDA Preparation Automation

Build ANDA Submissions with Confidence. Not Guesswork.

Regller transforms ANDA preparation into a structured, continuously evaluated, compliance-driven workflow.

Site Qualification Is Only Half the Story. You May Need ANDA.

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Digital ANDA Readiness Engine

Regller 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 to FS to Test to Validation evidence
  • Automatic cross-reference generation
  • Inspection-ready traceability reports

4. Risk and 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

ANDA Workflow

Automation and constant confirmation of quality is the priority.

  1. Project Created
  2. Document Package Selected
  3. Templates Copied to Project
  4. Authors Create Sections
  5. Compliance Engine Evaluates
  6. Gaps Identified
  7. Review and Approval
  8. Final Structured ANDA Package

Accelerate Your ANDA Submission

Connect with our team to learn how Regller can transform your quality management.

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