Quality & Regulatory Services

Focus on what you do best while TRE handles your compliance needs. Browse our services below.

At TRE, we understand the complexities and challenges in today's regulatory landscape. From product label review to international product registration, our suite of services is designed to provide you with expert guidance and support, ensuring your products meet all necessary requirements. Whether you're a startup or an established company, we've got you covered.

Ask the Expert

Ask the Expert

Label Review

Claims &
Substantiation

cGMP GAP
Analysis

International Product
Registration

Fractional
Head of Quality

Ask the Expert

Have a compliance question? Get an answer--free. It's your one-stop shop for answers. Just click the button below, ask a question, and look for an answer the next day, and sometimes sooner. Need to book a 15-minute call? Let's connect.

Why choose us:

Immediate Expertise: Gain access to seasoned professionals with a deep understanding of regulatory compliance. This ensures that your inquiries are met with accurate and insightful responses.
Efficient Resolution: Submit your question and receive a prompt reply, often within the next day, to keep your compliance processes moving forward without delay.
Flexible Communication: Whether you prefer a quick written response or a more in-depth 15-minute call, we adapt to your preferred style of communication to facilitate understanding and decision-making.

Label Review

Stop guessing and leave the tedious, boring, awful label reviews to TRE. TRE eats compliance pain like candy and you get peace of mind–along with detailed review and report of your label compliance. Use the button below to submit a PDF of your label and schedule an appointment to review the report together 48 hours later.

Why choose us:

Comprehensive Compliance Analysis: TRE meticulously examines every aspect of your label to ensure full compliance, providing you with a detailed report that not only identifies issues but also guides you through the resolution process.
Rapid Turnaround Time: Submit your label as a PDF and receive a thorough review and actionable feedback within 48 hours, accelerating your product’s journey to market.
Collaborative Review Sessions: Schedule an appointment to discuss the review findings, where we will walk you through each part of the report, ensuring clarity and undersatnding of the compliance requirements and next steps.

Claims & Substantiation

Is it a drug claim? What is a structure/function claim? What can I say about my product?! So much marketing copy, so many questions. Sometimes it's as simple as changing a word or two. Other times it's 100 pages of website content. Use the link below to submit your claims and schedule an appointment to review them together 48 hours later.

Why choose us:

Precision Editing: Whether it’s tweaking a word or overhauling 100 pages, we fine-tune your marketing copy to align with regulatory requirements, ensuring your product claims are both compliant and compelling.
Regulatory Expertise: Navigate the complex landscape of claims with our expertise, distinguishing between permissible product claims and prohibited drug claims, to safeguard your marketing strategies.
Prompt Review Process: Submit your marketing claims through our portal and have a comprehensive review completed within 48 hours, followed by a detailed discussion in our scheduled appointment to clarify and strategize the next steps.

cGMP GAP Analysis

Maybe you're a startup. You're selling products, but you haven't looked under the hood for compliance issues. You don't want a visit from the FDA right now, you're not prepared--you don't know what you don't know. Don't wait until the compliance check engine light comes on. Worse, don't wait until you get pulled over without compliance insurance. Know where you stand and what to prioritize. Schedule an appointment below to ground me in your business and get a cGMP GAP Analysis report a week later.

Why choose us:

Proactive Compliance Assessment: Identify and address potential regulatory and quality risks before they escalate into major issues, ensuring your operations stay ahead of compliance and avoid unexpected and unnecessary FDA scrutiny.
Tailored Business Insight: Ground us in your business specifics to receive a cGMP GAP Analysis that not only assesses your current compliance status but also provides actionable recommendations tailored to your unique operational needs.
Strategic Prioritization: Understand where you stand in the compliance spectrum and receive guidance on prioritizing actions to mitigate risks, streamline processes, and ensure continuous improvement towards full regulatory compliance.

International Product Registration

You thought navigating FDA regulations was hard? Try Australia, Canada, Europe, Mexico, China, Brazil–TRE has legalized and registered hundreds of products in 50+ global markets. Schedule an appointment below and let's grow your international footprint together.

Why choose us:

Global Market Expertise: With experience in legalizing and registering products across more than 50 international markets, TRE provides knowledgeable guidance to navigate the complex landscape of global regulations and expand your international presence.
Customized Registration Strategy: Develop a tailored approach for each target market, leveraging our understanding of regional regulatory nuances to streamline the registration process and maximize your product’s global reach.
Partnership for Growth: Collaborate with TRE to strategically grow your international footprint, benefitting from our extensive experience and support through every step of the product registration journey.

Quality & Regulatory Fractional Head

Access executive-level quality and regulatory compliance expertise without the full-time expense. TRE Fractional Head service offers strategic leadership tailored to lead small and mid-sized CPG companies through the complexities of compliance with a cost-effective solution. Schedule a call below and tell me about your business.

Why choose us:

Executive Expertise on Demand: Gain the strategic advantage of executive-level quality and regulatory compliance expertise, tailored to the specific needs of your business, without the overhead of a full-time executive position.
Cost-Effective Compliance Leadership: Leverage TRE’s Fractional Head service to navigate the complexities of compliance, providing small and mid-sized CPG companies with an affordable yet comprehensive solution for their quality and regulatory needs.
Customized Strategic Direction: Receive personalized guidance and leadership to steer your company through the quality and regulatory landscape, ensuring your business practices align with industry standards and promote sustainable growth.