GDP Consulting

Upholding Good Distribution Practices

Validant brings a long history of helping life science companies – from pharma and biotech to medical device and diagnostics manufacturers – to understand and adapt to global regulatory, compliance, and quality requirements for distribution.

Upholding good distribution practices (GDPs) is imperative to maintain product safety and quality of drugs and products in their delivery from the manufacturing facility to the end user. Validant will help you expertly navigate regulatory requirements related to post-market surveillance, ensure a robust quality management system is in place to cover your supply chain end-to-end, and instill confidence in the quality of your brand in the market.

We support quality and compliance throughout distribution via:

  • Quality Systems Development
  • Quality IT Systems
  • Lab Controls and Data Integrity
  • FDA/EMA/Health Authority Agency Intelligence
  • Rapid Response to Inspections
  • Remediation Support
  • On-Site Remediation
  • Consent Decree & Warning Letter Remediation Strategy
  • Organizational Assessment
  • Internal Audits
  • Authority Response
  • Staff Training
  • Support to Implement New/Revised Standards & Guidelines
  • Post-Market Surveillance
  • Quality Remediation
  • Quality Goals & Metrics
  • Effectiveness Assessments
  • Quality Operations Support
  • Management Review
  • Validation & Qualification
  • Risk Management
  • Laboratory Controls

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