QACV Consulting 2026 AI Program Development

NEW | AI Compliance Center of Excellence (AI CCoE)

Machine Learning-enabled Medical Devices (MLMDs), including Good Machine Learning Practice (GMLP) for Medical Devices: Guiding Principles

Artificial Intelligence (AI) Usage in Drug & Biological Product Development & Manufacturing Processes

AI/ML Compliance Assessments, including Vendor Audits, and AI/ML Validation Support

  • Dataset Governance
  • Documentation of Algorithm Development
  • Validation of Algorithms
  • Gap Assessments, and Remediation
  • Audits of AI/ML Software vendors

Training in AI/ML Regulatory Compliance

  • Training Programs and Courses
  • Tactical Training : What to do?
  • Strategic Training: Why ?
  • Ethical AI and Transparency

GxP Services

  • Development and Review of AI/ML Regulatory Submissions
  • Regulatory Agencies Inspection Preparation, including Mocking Inspections

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