Services – Compliance & Quality Support for Supplement Brands
Launch and Scale Your Supplement Brand With Confidence
At Blue Ocean Regulatory, we help two types of clients:
New Founders who need compliance support to launch their brand the right way.
Established Brands that need advanced regulatory systems, audits, and a fractional compliance VP to scale safely.
For New Founders – Start Right, Stay Compliant
Launch your brand without fear of FDA & FTC or Amazon roadblocks. If you’re just starting out, compliance can feel overwhelming. We break it down and give you the exact steps you need to launch.
Services for New Founders
Signature 1:1 Consultations and Online Training
For founders who want to learn the in and outs of the industry, how to find a manufacturer, price their product and understand compliance and get feedback on their concept.Label, Website and Marketing Review
Ensure your Supplement Facts, disclaimers, and claims are fully compliant.Amazon & Retailer Compliance
Pass Amazon’s review and meet retailer requirements like Whole Foods.Manufacturer Vetting & FSVP Support
Choose the right partner and ensure your imports meet FDA rules.Structure/Function Notifications
File correctly with FDA to avoid delays or red flags.Training on Supplement Requirements
Get your team up to speed on FDA/FTC basics in plain language.NHP Licensing (Canada)
Secure an NPN for legal sales in Canada.Formulation Compliance & Claims Substantiation
Build safe, effective formulas backed by science and within regulatory limits.
For Established Brands – Scale Safely With Quality Systems
Protect Your Growth With Robust Compliance & Oversight
If you’re already selling, now is the time to build systems that keep your brand safe as you scale.
Services for Established Brands (in addition to the above services):
SOP/QMS Build-Out & Fractional Compliance VP
Put structure in place with a pressure-tested full quality system or bring in compliance leadership.Manufacturer Audits
Make sure your suppliers and contract manufacturers are FDA/Health Canada ready.Specifications & Testing Programs
Lock in standards for every product, from potency to purity that go above and beyond GMP standards. .Shelf-Life & Stability Studies
Generate data that retailers and regulators expect.Recall & Adverse Event Programs
Be prepared with systems that protect customers and your brand reputation.Crisis Management Support
Immediate guidance if you face recalls, warning letters, or public issues.Claims Substantiation
Back up your product claims with real science to satisfy FDA and FTC.Ongoing Training
Keep your staff aligned with FDA/FTC expectations as your team grows.
Why Brands Trust Blue Ocean Regulatory?
Blue Ocean Regulatory has helped dozens of supplement startups move from idea to a fully compliant launch, while also guiding established brands into top retailers with solid compliance records. Our proactive reviews have saved clients from costly Amazon removals and FDA warning letters, and many companies rely on us as their fractional compliance VP when they need expert oversight without the expense of a full-time hire.
Our expertise is recognized across the industry—we’ve been invited as guest speakers at events hosted by the Council for Responsible Nutrition, featured in leading trade media such as Nutra-Ingredients USA, and interviewed on respected podcasts including the Nutracast Podcast, Health Supplements Business Mastery, and Hearts & Carts. These platforms highlight our role as trusted advisors in supplement compliance, reinforcing why brands of all sizes turn to Blue Ocean for guidance they can rely on.
The Blue Ocean Compliance Roadmap
Our process is designed to be clear, practical, and customized to each brand we work with. It starts with a Discovery Call, where we learn about your business stage, challenges, and immediate priorities. From there, we conduct a Vulnerability Gap Assessment to identify areas of risk in your current compliance or quality approach. Based on these findings, we build a Compliance Roadmap—a set of next steps that are tailored to your goals and prioritized according to your business needs. Once the plan is in place, we move into Execution, delivering label reviews, SOPs, audits, training, or other support with a focus on accuracy and speed. Finally, we provide Ongoing Support, whether that’s acting as your fractional compliance VP, monitoring updates to regulations, or guiding you through crisis situations such as recalls or warning letters.
Let’s Get Started.
Your brand deserves more than guesswork. Whether you’re just starting out or already on shelves, compliance isn’t optional—it’s the foundation of growth. With Blue Ocean Regulatory, you’ll have a partner who understands the rules, speaks the regulator’s language, and delivers clear, actionable solutions.