If you're searching for a GMP consultant for a dietary supplement company, you've probably already run into two names that keep surfacing: Boardley Consulting and Certify Consulting. Both work in the same regulatory lane — 21 CFR Part 111, the current good manufacturing practice regulation for dietary supplements — and both get recommended in the same conversations. That doesn't make them interchangeable.
I'm Jared Clark, a GMP compliance consultant at Certify Consulting, so I'll say up front that I have a stake in this comparison. But the goal here isn't to tell you Certify is "better" in the abstract. It's to give you the actual criteria that separate one GMP consulting engagement from another, so you can evaluate any firm — including mine — against something more solid than a homepage.
What a GMP Consultant Actually Does Under 21 CFR Part 111
Before comparing firms, it helps to be precise about what the job is. Part 111 requires dietary supplement manufacturers, packagers, labelers, and holders to establish and follow current good manufacturing practices. The regulation isn't a single checklist — it's organized into subparts that each carry their own documentation burden:
- Subpart H requires a master manufacturing record for every batch size and formulation, specifying methods and equipment.
- Subpart I requires a corresponding batch production record for each batch actually run.
- 111.70 requires you to establish specifications for identity, purity, strength, and composition; 111.75 requires you to verify that those specifications are met, not just claim them.
- 111.90 governs production and in-process controls, including reprocessing.
- Subpart D (111.25(c), 111.27(d)) requires cleaning and maintenance schedules for equipment and utensils.
A GMP consultant's job is to help a company build a quality system that satisfies these subparts in a way that survives an unannounced FDA inspection, not just a paper audit. That's the frame to hold both firms against.
How to Evaluate Any GMP Consulting Firm
Whichever firm you're considering, the same handful of questions cut through the marketing:
- Does the consultant work from your existing SOPs, or do they hand you a template library and walk away? A gap assessment that doesn't end in documents you actually use in production isn't worth much.
- Who does the work — the person you talked to on the discovery call, or a subcontractor you've never met? Ask this directly. Firms structure this differently, and it matters for continuity.
- Is the engagement scoped to pass an inspection, or to build a quality system that keeps passing them? These are different jobs. The first gets you through a specific date. The second changes how your operation runs.
- Do they have documented FDA regulatory experience, or only industry-side QA experience? Both are useful, but they teach you to see different things. A consultant who has read warning letters and Form 483 observations across multiple firms tends to spot the pattern before it becomes a citation.
- What happens after the engagement ends? Supplement companies that treat GMP as a one-time project tend to drift out of compliance within a year or two, because personnel turnover and process changes erode the system faster than most owners expect.
Boardley Consulting: What They're Known For
Boardley Consulting is Marian Boardley Consulting LLC — a solo practice Marian Boardley has run since 2008, built around Part 111 gap assessments, SOP development, and inspection readiness for supplement manufacturers. One thing she's specifically known for: a public database cataloging FDA Form 483 observations organized by Part 111 subpart, which gives a documented view of where inspectors actually cite gaps rather than a general impression. Running the firm as a solo practice also answers evaluation question #2 above by default — the person you talk to on the discovery call is the person who does the work, with no subcontractor layer in between. If you're evaluating her directly, the rest of the questions above still apply with full force: whether the deliverable is a customized quality system or a templated binder, and whether the engagement includes any post-implementation support or is a single fixed-scope project.
I'd rather you ask Boardley these questions directly than rely on secondhand characterization from a competitor's website — that's the honest way to evaluate any firm you're considering, including mine.
Certify Consulting: Approach and Philosophy
My approach at Certify Consulting starts from the same regulation everyone else is working from — 21 CFR 111 — but I structure engagements around a specific sequence. That sequence runs in three parts: a gap assessment against the actual subparts your product category triggers, documentation build-out that your own staff can maintain without me in the room, and inspection preparation that walks your team through what an investigator actually does during a Part 111 inspection, not a generic mock audit.
I hold a JD, MBA, PMP, CMQ-OE, CQA, CPGP, and RAC, which means the compliance work is informed by both the legal reading of the regulation and the quality-engineering side of building a system that holds up under production pressure. In practice, that shows up in how I scope an engagement: I want your quality system to reflect what your operation actually does, not what a template assumes a supplement manufacturer does. A liquid tincture line and a tableted multivitamin line trigger different parts of Subpart E, and a consultant who treats every SKU the same way is going to leave gaps.
If your company is early in its compliance build, the first 90 days matter disproportionately — see my breakdown of what that period should look like. If you're specifically in the supplement space and want the industry-specific framing, the dietary supplements page covers how Part 111 applies to your product category in more depth than this comparison can.
Side-by-Side: Questions to Bring to Either Firm
| Evaluation criterion | Why it matters | What to ask |
|---|---|---|
| Scope of regulation covered | Part 111 has 16 subparts (A through P); not every engagement covers all of them | "Which subparts does this engagement address?" |
| Deliverable format | Templates vs. custom SOPs affects whether staff can maintain the system | "Will the SOPs reflect our actual equipment and process, or a generic model?" |
| Who performs the work | Continuity and accountability depend on this | "Will the person I'm talking to now be on-site during the engagement?" |
| Inspection readiness component | FDA inspections test behavior, not just documents | "Does this include mock interview practice for how staff respond to an investigator?" |
| Post-engagement support | Compliance systems decay without maintenance | "What happens if we get a new Form FDA 483 observation six months from now?" |
| Credentials of the lead consultant | Determines depth of regulatory and quality-system expertise | "What certifications or regulatory background does the lead consultant hold?" |
This table isn't scored in either firm's favor — it's the rubric I'd want a prospective client to bring into a call with any consultant, mine included.
Which One Fits Your Company?
The honest answer is that firm fit depends more on your company's stage and product complexity than on brand reputation. A single-SKU capsule manufacturer contract-packing through a third party has a much narrower compliance surface than a company blending, encapsulating, and labeling multiple product lines in-house. The former may need a focused Subpart H and I documentation project. The latter needs a full quality system with change control, supplier qualification, and a functioning corrective action process — the kind of build-out that touches nearly every subpart in Part 111 at once.
If you're choosing between two firms, I'd weight the decision on three things: whether the consultant's stated approach matches the complexity of your operation, whether you can speak directly with the person doing the work before you sign, and whether the engagement is structured to end at inspection-readiness or to continue as your compliance system matures. A firm that's honest about which of those it does — and doesn't do — is worth more than one that promises all three without specifics.
If you want to see how a gap assessment and remediation project actually plays out in practice, Certify's case studies walk through real engagement structures rather than abstract service descriptions. And if you're comparing more than two firms, the broader guide to choosing a GMP consultant lays out the same evaluation framework at a wider angle.
A Word on Due Diligence
One thing I'd tell any supplement company owner, regardless of which consultant they hire: verify claims yourself where you can. If a consultant tells you they've handled FDA inspections, ask what the outcome was and what corrective actions resulted. If they tell you a template library is "FDA-compliant," ask them to point to the specific 21 CFR 111 citation each template section addresses — a template that doesn't map to a subpart citation is a guess dressed up as a document. This isn't paranoia. It's the same standard FDA investigators apply when they review your procedures: does the document actually correspond to the regulation, or does it just look like it does.
Frequently Asked Questions
Is Boardley Consulting or Certify Consulting better for a small supplement startup?
It depends on how complex your product line already is. A startup with a single co-packed SKU has a narrower Part 111 compliance surface than one blending and encapsulating multiple formulations in-house. Ask either firm how they'd scope an engagement for your specific product category before assuming firm size or reputation predicts fit.
What does 21 CFR Part 111 require that a GMP consultant should address first?
Most gap assessments start with Subpart H (the master manufacturing record) and Subpart I (batch production records), because these two subparts are the documents FDA investigators request first during an inspection. Specifications under 111.75 typically follow closely behind.
Can a supplement company pass an FDA inspection without hiring a consultant?
Yes — Part 111 doesn't require third-party consulting. Many companies build compliant quality systems in-house. A consultant is worth the cost when the internal team lacks bandwidth to build the documentation from scratch, or when leadership wants an outside read on gaps before FDA finds them first.
How long does a typical Part 111 gap assessment take?
Timelines vary by product complexity and how much existing documentation the company has, but a focused gap assessment covering the core subparts (H, I, and specifications under 111.75) typically runs a matter of weeks, not months. A full quality-system build-out for a multi-SKU operation takes longer.
What's the difference between a mock audit and real inspection preparation?
A mock audit typically checks whether documents exist and match a checklist. Real inspection preparation also trains staff on how to respond to an investigator's questions in real time — because FDA's Form 483 observations often stem from what an employee says during an interview, not just what's in the binder.
If you're ready to talk through what a gap assessment would look like for your specific product line, reach out directly and I'll walk you through how I'd scope it.
Last updated: 2026-09-11
Jared Clark
GMP Compliance Consultant, Certify Consulting
Jared Clark is a GMP compliance consultant and founder of Certify Consulting, specializing in FDA GMP requirements for pharmaceuticals, dietary supplements, cosmetics, and food manufacturing.