SOP/QMS Build-Out & Fractional VP of Compliance

For supplement and functional food brands, compliance doesn’t stop at having a clean label or qualified manufacturer. The FDA — and distributors like Amazon, Costco, and Whole Foods — expect your brand to have documented Standard Operating Procedures (SOPs) and a functioning Quality Management System (QMS).

But for most startups and emerging brands, hiring a full-time VP of Compliance or Quality isn’t realistic. That’s where we come in.

At Blue Ocean Regulatory, we build SOPs and scalable QMS frameworks tailored for supplement brand owners at all sizes and provide Fractional VP of Compliance services to give you leadership-level oversight without the full-time expense. Our goal: equip your brand with the infrastructure to meet FDA, FTC, CFIA, and Health Canada expectations while staying lean and fast-moving.

Why SOPs and a QMS Matter

  • Regulatory Requirement: Under 21 CFR 111 (supplements) and 21 CFR 117 (foods), you’re required to have written procedures for everything from product complaints to training to label updates. Health Canada requires documented GMPs for NHPs.

  • Retailer & Investor Expectation: Major retailers and investors routinely ask for SOPs, GMP policies, and quality manuals. Without them, your brand looks unprepared and high-risk.

  • Crisis Prevention: Many brand crises — mislabeled products, quality complaints, failed recalls — stem from the absence of clear procedures and records. A strong QMS reduces those risks.

  • Scalability: As your brand grows, SOPs and a QMS let you scale without reinventing the wheel each time a new challenge comes up.

What Our SOP/QMS Build-Out Covers

We don’t hand you a generic binder. We build a system tailored to your business model, manufacturing setup, and growth goals.

1. SOP Library Development

We draft and customize SOPs covering the critical areas regulators, retailers, and auditors expect, including:

  • Label Updates & Control – tracking and approving revisions.

  • Finished Product Specifications – documenting testing and release criteria.

  • Supplier & Manufacturer Qualification – risk-ranking, COA verification, audit requirements.

  • Complaint Handling & Adverse Events – intake, investigation, reporting.

  • Non-Conformance Management – corrective actions, root cause analysis.

  • Training & Recordkeeping – ensuring staff understand and follow procedures.

  • Retention Samples & Record Retention – archiving practices that satisfy regulators.

  • Website/Marketing Review – compliance checks for claims and disclaimers.

  • Crisis Management – recalls, public statements, and corrective actions.

2. Quality Management System (QMS) Framework

  • Document Control: Versioning, approvals, and secure storage.

  • Training Logs: Easy-to-use templates for ongoing compliance training.

  • KPI Dashboards: Track manufacturer performance, complaint trends, and audit findings.

  • Risk-Ranking Tables: Prioritize suppliers, ingredients, and processes based on risk level.

  • Custom Workflows: Tailored to your team size, sales channels, and product types.

3. Fractional VP of Compliance

For brands not ready to hire full-time leadership, we act as your outsourced VP of Compliance. That means:

  • Executive-level oversight of compliance strategy.

  • Direct support on audits, recalls, and regulatory inspections.

  • Guidance for cross-functional teams (marketing, ops, R&D).

  • Representation in calls with investors, retailers, and regulators.

  • Monthly or quarterly check-ins to keep your QMS active and effective.

This gives you senior leadership at a fraction of the cost of hiring full-time.

Common Challenges We Solve

  • Founders don’t know where to start: Many think “our manufacturer handles it” but brand owners remain legally responsible.

  • SOPs borrowed from manufacturers don’t fit: Generic documents often don’t reflect the brand-owner role or sales channels.

  • Systems that sit on a shelf: Many QMS binders are never used. We create practical, usable systems your team can actually follow.

  • Lack of accountability: Without leadership, SOPs become “paper compliance.” Our fractional VP role keeps the system alive.

  • Gaps exposed during growth: Retailers, distributors, and investors start asking for documentation as brands scale — and many aren’t prepared.

Why Brands Work With Blue Ocean Regulatory

We know supplement compliance from every angle: startup launches, Amazon sellers, Canadian NHP approvals, and multinational expansions. That means we design SOPs and QMS frameworks that fit your reality that are lean enough for early-stage teams, robust enough for retailers and FDA audits.

Our insights have been featured in NutraIngredients USA, we’ve been invited to guest speak at events hosted by the Council for Responsible Nutrition, and interviewed on The Nutracast Podcast. Brands trust us because we translate regulatory expectations into plain-language systems that founders, marketers, and operations staff can actually follow.

On-Site or Virtual Build-Out

  • On-Site: We spend time with your team, walk through workflows, and tailor SOPs in real time.

  • Virtual: We guide your team through document reviews and implementation via Zoom/Teams, with document sharing through secure portals.

  • Hybrid: A mix of both, ideal for growing brands who want extra handholding at launch.

Next Steps

If your brand doesn’t yet have SOPs or a functioning QMS — or if your documents are outdated or sitting unused — now is the time. FDA inspections, retailer reviews, and investor due diligence are happening earlier and more often.

Schedule an SOP/QMS Build-Out Consultation with Blue Ocean Regulatory today. We’ll design a scalable compliance system, act as your Fractional VP of Compliance, and give you the infrastructure to grow your supplement or food brand with confidence.