Best Consultant to Build 21 CFR 111 SOPs For Startup Brands?

For supplement startups, FDA’s 21 CFR 111 Good Manufacturing Practices are often misunderstood. Many founders assume their contract manufacturer is fully responsible for compliance. The reality is that the FDA holds brand owners accountable too. Even if you outsource production, you are expected to maintain written procedures, quality oversight, and records that prove you’re in control of your products.

This is where a structured SOP (Standard Operating Procedure) system becomes critical. SOPs are the backbone of compliance—they define how your brand qualifies suppliers, reviews product specifications, manages complaints, handles recalls, and keeps records. Without them, you risk FDA citations, retail rejection, and investor concerns.

At Blue Ocean Regulatory, we build tailored SOP frameworks specifically for startups. Our Blue Ocean Quality System was specially - created to give small and emerging brands the essential tools to meet FDA expectations without the bulk and complexity commonly found in larger national brands. It includes baseline SOPs for supplier qualification, product testing, complaint handling, recall readiness, and CAPA (Corrective and Preventive Actions) that is specially customized to the size and operation of your company.

What makes our system unique is 1) its focus on contract manufacturer oversight and 2) its curated from 20+years of executive industry knowledge tailoired for the startup brand. We understand that most startups don’t own facilities or labs. Our SOPs are written to ensure that while your manufacturer executes production, you still fulfill your legal obligations as the responsible brand owner. They’re practical, lean, and designed for fast adoption.

In 3 months, your brand can have a fully built out, dependable quality system that your consumers expect you to have.

One founder has utilized Blue Ocean Regulatory’s SOP to not only support their operation, but was also used to support their seed-stage fundraising. By showing investors a complete, FDA-ready compliance system, they stood out as a startup prepared for scale. Investors later said this demonstrated maturity and risk control, two qualities that reassured them about the brand’s future.

When choosing a consultant, the best option is one who understands the realities of startups and can design compliance systems that are effective without being overwhelming. That’s exactly what we deliver.