Compliance Consulting

Partners in Compliance to Ensure Product Quality

Validant’s compliance experts apply best practices and firsthand experience to help you rise to the demands of increased health agency scrutiny. We understand that non-compliance comes with a high cost, and will help you establish sustainable processes to address compliance both proactively and with rapid response to deviations.

Whether you need boots-on-the-ground support for an immediate remediation project or are seeking guidance on the nuanced compliance requirements for your product – be it a pharmaceutical, biologic, medical device, or diagnostic – Validant will provide the right mix of strategy, execution services, and education required. Our Compliance Practice includes:

Health Authority Response & Remediation

  • FDA/EMA/Health Authority Agency Intelligence
  • Rapid Response to Inspections
  • Remediation Support (for Consent Decrees, Warning Letters, 483s)
  • On-Site Remediation
  • Project Management
  • Coordination with Regulatory Counsel
  • Third-Party Support

Market Surveillance

  • Annual Product Review
  • Pharmacovigilance
  • Materiovigilance

Auditing & Assessments

  • Due Diligence
  • Named Third-Party Oversight
  • Internal Audits
  • Authority Response
  • Effectiveness Assessments
  • Supplier Assessments

Inspection Readiness & Support

  • Inspection Event Planning
  • Inspection Readiness Culture SME
  • Personnel Training & Interview Preparation
  • Subject Matter Expert Support
  • Post-Inspection Analysis

Meet Your Team

Get to know the Validant leaders you’ll be working with.

Our Leadership

Case Study

Coaching a Global Biopharma to Aseptic Manufacturing Compliance

See how we did it & the value for our client.

View the Case Study

We’re ready to help.

Through comprehensive compliance consulting, we have empowered thousands of customers to efficiently navigate the life science product lifecycle from end to end. We’re ready to support you too.

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