Regulatory Compliance
& Quality Management

Focus on what you do best—TRE will handle your compliance needs.

Most small businesses and startups just have a few questions, need a label reviewed, or are curious about what kinds of claims they can make for their dietary supplement or food. 

Some need a food safety plan, a HACCP plan, or a cGMP GAP analysis. And some just want the headache to go away—so they can finally sleep at night without wondering whether the FDA or FTC will shut down the business they’ve worked so hard to get off the ground. 

Ask the Expert

Label Review

Claims &
Substantiation

cGMP GAP
Analysis

International Product
Registration

Fractional
Head of Quality

J.C.
The Regulatory Unicorn

Have a compliance question?

Get an answer—free and directly from me. 

This is your one-stop shop for straight answers on food and supplement compliance. Click the button, ask your question, and hear back within a day—sometimes sooner. Need a deeper dive? You can schedule a call, too. 

Why choose TRE Regulatory Unicorn? 

  • Immediate Expertise 
    Talk to me—not a chatbot or junior rep. I bring years of hands-on regulatory experience, so you get real answers, not guesswork. 

  • Fast Turnarounds 
    Submit your question and I’ll get back to you quickly—usually by the next day—so you’re never stuck waiting to move forward. 

  • Flexible Support 
    Want a quick written reply? Great. Prefer a call? I have you covered. Pick what’s best for you. 

Label Review

Label reviews don’t have to be a headache—I'll handle the fine print for you. 

TRE handles compliance pain like candy, so you can have peace of mind. You’ll get a detailed review and report of your label’s compliance status—fast. 

Just send over a PDF of your label, and we’ll schedule a review call 48 hours later to walk through it together. 

Why choose me:

  • Comprehensive Compliance Check 
    I review every detail of your label to flag any compliance issues—and provide clear, actionable steps to fix them. 

  • 48-Hour Turnaround 
    Submit your label as a PDF and get a full review and feedback report within two business days. 

  • Live Walkthrough 
    Book a call to go over the results together. I’ll walk you through each part of the report so you understand what’s working, what needs fixing, and what to do next. 

Claims & Substantiation

Is it a drug claim? A structure/function claim? What can you say about your product? 

Marketing while staying compliant gets confusing fast. 
Sometimes it’s just a word or two. Other times, it’s 100 pages of website copy. 

Use the link below to submit your claims and book a review session—usually scheduled within 48 hours. 

Why choose me:

  • Whether it’s a small tweak or a full rewrite, I’ll make sure your claims are clear, compliant, and still compelling. 

  • Regulatory Know-How 
    I’ll help you confidently navigate what’s allowed—and what crosses the line—so your marketing stays effective and safe. 

  • Fast Turnaround 
    Send your copy, and I’ll review it within 48 hours. Then we’ll hop on a call to go over everything and map out your next steps. 

cGMP GAP Analysis

You’re selling products. Maybe you’re a startup. Maybe things took off faster than expected. 

But you haven’t looked under the hood for compliance issues yet. An FDA visit? Not something you want catching you off guard. And the truth is, you don’t know what you don’t know. 

Don’t wait for the compliance check engine light to flash. Find out where you stand, what’s missing, and what to prioritize. 

Use the link below to schedule a call where you can walk me through your business. You’ll receive a tailored cGMP GAP Analysis report within a week. 

Why choose me:

  • Proactive Compliance Assessment 
    Identify and address potential compliance gaps before they become costly problems. Stay ahead of FDA scrutiny and protect your business. 

  • Tailored Business Insight 
    Compliance may be black and white, but every business runs differently. I take the time to understand your operations so the report reflects where you are—and what needs your attention first. 

  • Clear Action Steps 
    You’ll leave with a clear understanding of your compliance status and a focused plan for what to tackle next. 

International Product Registration

Think FDA regulations are tough? Try navigating Australia, Canada, Europe, LATAM, ASEAN—even Antarctica. 

TRE has helped legalize and register hundreds of products in 50+ global markets. Schedule an appointment below and let’s grow your international footprint—together. 

Why choose me:

  • Global Market Expertise 
    I’ve registered products in over 50 international markets. I understand the regional requirements, the red tape, and the kind of roadblocks that stall progress—and how to avoid them. 

  • Customized Strategy 
    There’s no one-size-fits-all approach. I’ll help you map out a clear plan for each market, based on what’s actually required—not guesswork or generic checklists. 

  • Partnership for Growth 
    Expanding globally takes more than paperwork. I’ll guide you through each step of the registration process, helping you move efficiently and make smart decisions along the way. 

Quality & Regulatory Partner/Fractional Head

Get executive-level quality and regulatory expertise—without the full-time salary. 

TRE’s Fractional Head service offers strategic leadership tailored for small and mid-sized CPG companies navigating the complexities of compliance. It’s a cost-effective way to stay ahead of regulatory demands without bringing on a full-time hire. 

Schedule a call below and tell me about your business. 

Why choose me:

  • Executive-Level Expertise 
    Bring senior quality and regulatory leadership into your business—tailored to your needs, without the overhead of a full-time executive. 

  • Cost-Effective Compliance Leadership 
    TRE’s Fractional Head service gives you high-level strategy and oversight, making it easier for growing CPG companies to stay compliant and scale smart. 

  • Customized Strategic Direction 
    You’ll get personalized guidance that aligns your operations with industry standards and sets you up for long-term, sustainable growth. 

"You aced our label test. We've sent this to consultants for years and nobody has ever caught everything."

Physician's Choice, CO

Compliance?
I know a guy.

Compliance isn't just a checklist--it's a passion.
Just Ask the Expert, it's free.

Have a Question? Let’s Chat.

When you’re ready to begin your project, let’s connect.