Quality Consulting

Ambassadors of Quality Through the Product Lifecycle

Validant offers a unique portfolio of expertise in the Quality discipline, including strategic support, technical expertise, and project-based solutions. Everything we do is centered around upholding product and process quality within the context of your unique business realities.

We understand that the cornerstone of any quality improvement program is sustainability. Our programs engage your leadership and teams at all levels to ensure the proper control processes are in place to maintain quality across development, manufacturing, and distribution of your product. Our Quality Practice includes:

Quality Systems Design, Strategy & Implementation

  • Quality Systems Development
  • Data Integrity
  • Quality IT Systems
  • Quality Remediation
  • Management Controls
  • Risk Management
  • Design Controls
  • Train and Qualify Staff
  • New/Revised Standards & Regulations

Lab Controls & Data Integrity

  • Quality Control Operations Assessment
  • Data Integrity Remediation
  • Quality Control Organizational Assessment
  • Interim Subject Matter Experts & Staffing

Quality Operations Support

  • Management Review
  • Validation & Qualification
  • Risk Management
  • Laboratory Controls
  • Batch Review
  • Quality Engineering
  • Exceptions
  • Post Market Surveillance

Quality Systems Auditing & Assessment

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

Meet Your Team

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

Our Leadership

Case Study

Confirming Application Integrity to FDA as Third-Party Reviewer

Explore how we executed on-site review of 48 products at the client’s site in India in four months.

View the Case Study

We’re ready to help.

Through comprehensive quality 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.

Request a Consult to Get Started