About Lab Integrity Pro

Your Partner in Laboratory Excellence

Led by experts with over a decade of experience in GxP environments, we specialize in data integrity, regulatory compliance, and quality systems for laboratories worldwide.

10+Years GxP Experience
100%Audit Success Rate
3Major CROs

Our Mission

To revolutionize pharmaceutical compliance through AI-powered automation, reducing costs and accelerating the journey from drug discovery to FDA approval.

Lab Integrity Pro was founded on a bold vision: that artificial intelligence can transform how laboratories manage compliance—making it faster, more accurate, and dramatically more cost-effective. We combine over a decade of hands-on pharmaceutical experience with cutting-edge AI to deliver solutions that were impossible just years ago.

We understand the pressures modern laboratories face: shrinking budgets, expanding regulatory requirements, and the urgent need to bring life-saving therapies to patients faster. Traditional compliance approaches can&apost keep pace. That&aposs why we've developed AI-driven solutions that don'&apos just meet compliance standards—they fundamentally reimagine how quality work gets done.

Lab Integrity Pro consultant

What Sets Us Apart

Real experience. Practical solutions. Proven results.

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Pharma Experience

Our quality consultants each have a minimum of ten years' experience working in various GLP and GMP labs, bringing real-time insights from the field, not outdated consulting knowledge.

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Automation Pioneer

Transforming paper-based processes into fast, compliant digital workflows. Our AI-supported automation tools eliminate bottlenecks, enhance data integrity, and give your lab the efficiency edge required in regulated GxP environments.

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ADC Specialization

Deep expertise in large molecule antibody drug conjugate treatments for cancer - one of the most complex and regulated areas of bioanalysis.

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From Manual to Digital

Personally reviewed thousands of handwritten notebooks, understanding exactly where automation can save hours without compromising compliance.

Our Areas of Expertise

Comprehensive knowledge across all aspects of laboratory compliance

Regulatory Compliance

  • FDA 21 CFR Parts 11/58/210/211
  • EMA Guidelines
  • ICH M10 2022
  • ALCOA+ Principles
  • GLP/GMP Standards

Data Integrity

  • Audit Trail Review
  • Electronic Records
  • Data Lifecycle Management
  • Metadata Handling
  • System Validation

Quality Systems

  • SOP Development
  • CAPA Management
  • Deviation Handling
  • Change Control
  • Risk Assessment

Laboratory Operations

  • Method Validation
  • Sample Analysis
  • Equipment Qualification
  • Training Programs
  • Documentation Practices

Our Core Values

The principles that guide everything we do

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Precision & Accuracy

Every template, every consultation, every solution is crafted with meticulous attention to detail and regulatory requirements.

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Client Partnership

We view ourselves as an extension of your team, invested in your success and committed to your laboratory's excellence.

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Continuous Learning

The regulatory landscape evolves constantly. We stay current so you can stay compliant.

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Practical Innovation

We combine proven methodologies with innovative approaches to solve complex compliance challenges.

Industries We Serve

Supporting laboratories across diverse sectors

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Pharmaceutical

Drug development, manufacturing, and quality control laboratories

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Biotechnology

Biologics, biosimilars, and advanced therapy development

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Contract Research

CROs and CMOs supporting multiple clients and studies

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Clinical Diagnostics

CLIA-certified and diagnostic testing laboratories

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Academic Research

University and institutional research laboratories

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Government

Federal and state laboratory facilities

Our Approach

A systematic methodology for sustainable compliance

1

Assess

We begin by understanding your current state, challenges, and compliance goals

2

Design

Custom solutions are developed to address your specific needs and requirements

3

Implement

Practical tools and processes are deployed with minimal disruption to operations

4

Support

Ongoing guidance ensures sustainable compliance and continuous improvement

Ready to Elevate Your Laboratory's Compliance?

Discover how Lab Integrity Pro can help you achieve excellence in data integrity and regulatory compliance

Explore Our SolutionsSchedule a Consultation