THC — Tracey Harris Consulting

Your Preferred Expert for Global Quality & Regulatory Compliance

As a former FDA Investigator and Baxter International Auditor, I bring over 16 years of hands-on industry experience to organizations that need trusted, practical guidance. With a Master’s and Bachelor’s degree in Chemistry, and a career spanning back to 2009, I’ve built my reputation as the go-to resource for quality, regulatory, and compliance support.

The easiest inspection is the one you’re ready for.

Where My Expertise Meets Your Industry — and How We Can Work Together

  • ✔ Quality Management Systems (QMS)
    ✔ Auditing & Inspection Readiness
    ✔ Quality Assurance & Quality Control (QA/QC)
    ✔ Training, Learning & Development
    ✔ Health Authority Inspection Preparation & Support
    ✔ Risk Mitigation & Process Improvement

  • I work with companies across a wide range of regulated industries, including:

    • Pharmaceuticals & Biologics

    • Food & Beverages

    • Medical Devices

    • ISO-Regulated Industries (Defense, Automotive, Paper Products, and more) text goes here

  • My clients include:

    • Small and mid-size manufacturers

    • Global innovators

    • CMOs and CDMOs

    • Startups and emerging businesses

    • Corporate consulting teams in need of subject-matter expertise

Book

If you're seeking straightforward, industry-tested support from a consultant who understands both regulatory expectations and real-world business challenges, THC — Tracey Harris Consulting is your trusted choice.

Customized Support. Reliable Compliance.

Whatever your challenges, we provide the right support to keep you on track.

  • ✔ Supplier & Contract Manufacturer (CMO) Audits

    • Active Pharmaceutical Ingredients (APIs)

    • Drug Substance Manufacturers

    • Raw Material Suppliers

    • Packaging & Labeling Vendors

    • Excipients & Supporting Materials

    ✔ Quality Control (QC) Laboratory Audits

    • Analytical Testing Facilities

    • Microbiological Testing Labs

    • Stability Testing Programs

    • Organoleptic (Sensory) Testing

    • Method Validation & Verification

    ✔ Service Provider Audits

    • Sterilization Providers

    • Packaging & Labeling Services

    • Warehousing & Controlled Storage Facilities

    • Distribution & Transportation Partners

    ✔ Specialty Audits

    • Internal & Site Audits

    • Sterile Manufacturing Facilities

    • Stability Program Oversight

    • Data Integrity & Compliance Reviews

  • Modern Inspection Support

    Regulatory inspections evolve — so should your approach. I help companies apply current Health Authority intelligence, proven strategies, and practical tools to strengthen inspection outcomes and reduce risk.

    Inspection Readiness

    Inspections can happen anytime, often with little notice. True readiness is not perfection, but an ongoing process. I support companies with:
    ✔ Pre-planned inspection logistics
    ✔ Confident, well-prepared SMEs
    ✔ Up-to-date knowledge of Health Authority expectations
    ✔ Coaching on handling complex quality discussions
    ✔ Mock inspections led by a former FDA investigator

    Inspection Remediation

    Modern Inspection Support

    Regulatory inspections evolve — so should your approach. I help companies apply current Health Authority intelligence, proven strategies, and practical tools to strengthen inspection outcomes and reduce risk.

    Inspection Readiness

    Inspections can happen anytime, often with little notice. True readiness is not perfection, but an ongoing process. I support companies with:
    ✔ Pre-planned inspection logistics
    ✔ Confident, well-prepared SMEs
    ✔ Up-to-date knowledge of Health Authority expectations
    ✔ Coaching on handling complex quality discussions
    ✔ Mock inspections led by a former FDA investigator

    Inspection Remediation

    When observations happen, swift, strategic action is key. I provide expert support to help you:
    ✔ Analyze root causes
    ✔ Develop effective corrective actions
    ✔ Craft clear, defensible regulatory responses
    ✔ Restore inspection readiness and avoid repeat findings

  • ✔ Regulatory-Compliant Documentation
    Development and maintenance of quality standards and standard operating procedures (SOPs) that meet the latest regulatory requirements for all applicable markets

    ✔ User-Friendly Documentation
    Creation of QMS documents that are clear, accessible, and easy to follow for end users—without compromising regulatory or internal requirements

    ✔ Integrated, Cohesive Documentation
    Alignment of quality standards, SOPs, work instructions, and templates to ensure consistency, clarity, and seamless integration across your entire QMS

    ✔ Streamlined, Efficient Quality Systems
    Optimization of quality processes by removing unnecessary or non-regulatory requirements, simplifying procedures, and reducing resource burden without sacrificing compliance

  • You’ve Got Questions — I Provide Straightforward, Practical Answers.

    ✔ Expert Guidance on Complex Quality & GMP Challenges
    Personalized advisement to help you navigate difficult quality, compliance, and Good Manufacturing Practice (GMP) issues

    ✔ Regulatory Interpretation & Application
    Clear, actionable insight to help you understand and apply evolving regulatory requirements to your operations

    ✔ Clarity on New Guidance Documents
    Support in interpreting new industry guidance documents, ensuring your organization stays aligned with the latest expectations

    ✔ Health Authority Trends & Data Analysis
    Analysis of inspection trends, regulatory data, and enforcement activity to help you anticipate agency focus areas and stay inspection-ready

    ✔ User-Friendly Documentation
    Creation of QMS documents that are clear, accessible, and easy to follow for end users—without compromising regulatory or internal requirements

    ✔ Integrated, Cohesive Documentation
    Alignment of quality standards, SOPs, work instructions, and templates to ensure consistency, clarity, and seamless integration across your entire QMS

    ✔ Streamlined, Efficient Quality Systems
    Optimization of quality processes by removing unnecessary or non-regulatory requirements, simplifying procedures, and reducing resource burden without sacrificing compliance

  • Helping Teams Strengthen Compliance Through Practical, Expert-Led Training

    ✔ Topic Expertise
    Designed to build confidence and compliance across a wide range of key areas, including:

    • Inspection Readiness

    • Good Manufacturing Practices (GMPs)

    • Quality Systems (including investigations and root cause analysis)

    • Facilities & Equipment (maintenance, design, cleaning validation)

    • Utilities (water systems, steam, HVAC)

    • Material Management & Supplier Qualification

    • Packaging & Labeling Compliance

    • Contamination Control Strategies

    • Quality Control (QC) Laboratory Operations

    • Production Control & Process Oversight

    • Data Integrity Principles
      …and more, tailored to your organization's needs

    ✔ YouTube Community
    Stay connected through my YouTube channel, where I share practical FDA compliance tips, insider insights, and updates on the latest regulatory expectations.

    Subscribe today to stay informed and empowered.

    ✔ Recent Trainings Delivered
    A snapshot of relevant, real-world trainings provided to organizations, helping teams improve compliance, inspection readiness, and operational excellence.

Contact Us

  • Drugs

    Prescription & OTC Drug Support
    We offer GLP, GCP, and GMP solutions for biologics, vaccines, small molecules, APIs, and drug substances. Expertise includes sterile injectables, oral solids, ophthalmics, and topicals, with support extending to labs, storage, and distribution.

  • Medical Devices

    Medical Devices

    We provide quality and GMP compliance solutions for Class I, II, and III medical devices, supporting every stage from development to post-market oversight.

  • ISO - Certified Products

    We provide quality and GMP compliance support for food products, dietary supplements, and beverages, ensuring alignment with regulatory standards across manufacturing and distribution.

  • Laboratories

    We deliver quality and regulatory support for ISO-certified products across a range of industries, including raw materials, defense, paper goods, flooring, and other non-FDA regulated categories. Explore our service offerings to learn how we can support your compliance needs.

As a Quality Consultant in the pharmaceutical and medical device industries, I serve a vital role in safeguarding patient health and safety by ensuring that products meet high standards of quality. My work reflects integrity and excellence, driving meaningful change and innovation that enhances healthcare outcomes. I am motivated by the knowledge that I contribute to the well-being of others, living out my purpose by serving the community and embodying my faith through my commitment to quality and ethical practices. Each day, I make a significant impact, aligning my career with a higher calling to create a healthier world.

— Tracey L Harris

Founder

Welcome! I’m Tracey Harris, a dedicated Quality Consultant with over 16 years of specialized experience in quality and regulatory auditing. My journey began as a pharmaceutical investigator with the FDA, where I developed a profound understanding of compliance and safety. I advanced my career as a Global Quality Technical Consultant for Baxter Healthcare, honing my skills in delivering excellence in quality management.

Questions before getting started? Get in touch.

Compliance isn’t optional — it’s your license to operate.