We provide GxP compliance, quality, risk management, and validation consulting services.

Quality

Validation Consulting offers GxP quality and compliance consulting services to resolve FDA enforcement actions. Our quality and compliance consultants help biotech, pharmaceutical, and medical device manufacturers’ with their Quality Management Systems to ensure that their products consistently meet applicable regulatory requirements.

COMPLIANCE

Compliance is a CULTURE; a way of life for Validation Consulting, Inc.  While compliance may feel like a daunting task in the healthcare industry, it doesn’t have to be.  When an organization makes compliance a part of an everyday routine, it becomes a culture, and it becomes second nature.  Our resources aren’t just focused on simply ensuring compliance; they are experts at creating a compliant culture.

VALIDATION

Validation is our niche. Unlike any other validation-consulting firm, our Subject Matter Experts have extensive knowledge providing validation master plans, computer systems validation, equipment qualifications, process validation, and test method validation services. Sit with us and see what makes us different.
  • …I recognized immediately their leadership and expertise which supported the end result, an amazing document that I see being a foundation of risk management at this organization.

    Project Manager, Med Device Company