Validant

About Validant

At Validant, our vision is to ensure safe and reliable access to the world’s life-saving healthcare products. As the leading Quality, Compliance, and Regulatory consulting firm, we blend industry expertise with innovation to create custom solutions for companies on the frontier of health.

The Validant network represents the largest assembly of leading engineers, scientists, clinicians, and specialists in the field. With deep experience working within and alongside the FDA, health authority, and other regulatory agencies, we understand how to navigate the complexities fac...

  • US
  • 2019
    On CPHI since
  • 250 - 499
    Employees
Company types
Consultancy
Contact info

Products from Validant (5)

  • Inspection Readiness & Support

    Product Inspection Readiness & Support

    • Inspection Event Planning • Personnel Training and Interview Preparation • Subject Matter Expert Support • Post-Inspection Analysis
  • Quality Operations Support

    Product Quality Operations Support

    • Management Review • Validation and Qualification • Risk Management • Laboratory Controls • Batch Review • Quality Engineering • Exceptions • Post Market Surveillance
  • Health Authority Enforcement Response & Remediation

    Product Health Authority Enforcement Response & Remediation

    • FDA/EMA/Health Authority Agency Intelligence • Rapid Response to Inspections • Remediation Support • On-Site Remediation Project Management • Coordination with Regulatory Counsel • Third-Party Support
  • Laboratory Controls & Data Integrity

    Product Laboratory Controls & Data Integrity

    • Quality control Operations Assessment • Data Integrity Remediation • Quality Control Organisational Assessment • Interim Subject Matter Experts • Interim Management Staffing
  • Quality Systems Design, Strategy & Implementation

    Product Quality Systems Design, Strategy & Implementation

    • Quality Systems Development • Data Integrity • Quality IT Systems • Quality Remediation • Management Controls • Risk Management • Design Controls • Project Management • Train and Qualify Staff