FDA Compliance & Quality Management Services

Your comprehensive partner for regulatory excellence. With 20+ years of specialized experience in cGMP, CSV, CQV, and regulatory compliance, we provide complete quality management solutions from emergency crisis response to strategic system development.

Our services span the full spectrum of quality management needs: emergency FDA inspection support, complete QMS implementation, EU AI Act compliance, FDA-ISO harmonization preparation, and cutting-edge AI development for quality professionals. Whether you need immediate crisis response or long-term strategic planning, we deliver measurable results with proven methodologies.

IMPORTANT REGULATORY UPDATES:

  • EU AI Act: Active enforcement since February 2025 - immediate compliance required for companies selling AI medical devices
  • FDA-ISO 13485 Harmonization: February 2026 QMSR deadline approaching - strategic preparation must begin now

Every engagement includes personalized expert guidance and the promise of turning regulatory challenges into competitive advantages.

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Emergency Services

  • FDA Inspection Emergency Response
  • Critical Audit Failure Recovery
  • Emergency Deviation Investigation & CAPA Support

Core Quality Services

  • ISO 13485:2016 QMS Implementation
  • Complete QMS Transformation
  • FDA 21 CFR Part 820 Compliance
  • Risk Management (ISO 14971:2019)
  • QMS Gap Assessment
  • Internal Audit Program Development
  • Audit Readiness Review
  • CAPA System Improvement

EU AI Act Compliance

  • Emergency AI Act Compliance
  • AI Quality Management System

FDA-ISO 13485 Harmonization (February 2026 QMSR Deadline)

  • QMSR Readiness Assessment
  • FDA-ISO 13485 Harmonization Implementation
  • QMSR Transition Consulting
  • Harmonized QMS Documentation

AI Development & Training

  • Custom AI Agent Development
  • AI Integration
  • AI Compliance Workshops