GMP Consulting

Applying Robust Controls to Ensure Repeatable Quality

Validant offers a unique portfolio of expertise in the GMP compliance discipline, including strategic support, technical expertise, and project-based solutions.

Whether in support of audits, marketing claims, or in response to enforcement actions, our experts help you strategize and execute the process of post-market vigilance. We’ll help develop your program, author validation master plans, write your protocols, execute testing, write reports, and provide Quality and/or named third-party oversight.

Led by a team of proven GMP experts, who have solved manufacturing challenges like yours before, everything we do is in partnership with you and tailored to your unique needs and business objectives.

We support your ability to uphold manufacturing excellence through:

  • Regulatory Strategy Operations
  • Drug & Device Labeling
  • Lab Controls and Data Integrity
  • Quality Control Operations Assessment
  • Quality Control Organizational Assessment
  • Quality Systems Development
  • Quality IT Systems
  • Quality Remediation
  • Management Controls
  • Risk Management
  • Design Controls
  • Rapid Response to Inspections
  • Remediation Support
  • On-Site Remediation
  • Organizational Assessment
  • Quality Goals and Metrics
  • Internal Audits
  • Authority Response
  • Change Management

  • Outsourcing Strategy
  • Due Diligence
  • Validation & Qualification
  • Risk Management
  • Management Review
  • Laboratory Controls
  • Batch Review
  • Quality Engineering
  • Quality Operations Support
  • Effectiveness Assessments
  • Exceptions
  • Rapid Response to Inspections
  • Health Authority Response & Remediation
  • Consent Decree & Warning Letter Remediation Strategy
  • Product Gap Analysis & Remediation
  • Named Third-Party Oversight

How can we help you?

Tell us what you’re looking to achieve.
We’ll put our experience to work on your specific problem.

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