An Inspection Is Coming
FDA, state program, or customer audit on the calendar and no honest baseline. You need to know what's findable before someone comes to find it.
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Service · Flagship Engagement
Know every gap before the inspector does.
Inspections don't fail on the things you know about — they fail on the gaps nobody mapped: the procedure the floor doesn't follow, the record that doesn't exist, the owner nobody named. Our flagship assessment finds all of it in four weeks, ranks it by risk, and hands you a sequenced plan to close it. Then we stay and execute it with you — full validation, not just a findings report. Fixed fee, defined scope, no hourly meter running.
WHY NOW
Four weeks. One price. Three deliverables.
The engagement is deliberately bounded: long enough to be thorough, short enough to act on.
4 WeeksWeek 1 — remote document review. Week 2 — on-site walkthrough and interviews. Week 3 — gap analysis. Week 4 — leadership readout with the full package.
Fixed feeScoped in your statement of work and agreed up front — no hourly meter, no surprise invoices, no incentive to stretch the work.
3 DeliverablesA prioritized gap register, a sequenced remediation roadmap, and starter templates your team keeps — the evidence foundation, not just a findings list.
WHERE IT BREAKS
The four situations that trigger an assessment.
Most assessments start in one of these moments — and most teams wish they'd started sooner.
Documentation Doesn't Match the Floor
SOPs describe one operation; the floor runs another. The gap between the two is exactly what inspectors document — as observations.
Nobody Owns the Gaps
Everyone knows things are thin somewhere. Nobody has the full list, the risk ranking, or the authority to sequence the fixes. We produce all three.
Last Time Didn't Really Close
The 483 response went out, the commitments were made, and the evidence was never fully built. The follow-up inspection is where that bill comes due.
OUR METHOD
How the four weeks run.
A fixed cadence your team can plan around — with clear asks of your people at each stage.
Week 1 — Document Review (Remote)
We review your procedures, records, and quality files remotely: what the system claims, where the evidence is thin, and what to probe on-site. Minimal disruption to your team.
You receive: a document review findings log — what was reviewed, what’s missing, and exactly what we’ll probe during the walkthrough.
Week 2 — Walkthrough & Interviews (On-Site)
Two to three days on your floor: observing real workflows, interviewing operators, QA, and leadership, and testing whether the documents describe reality.
You receive: walkthrough and interview notes tied to specific requirements — observations, quotes, and photo-documented evidence references.
Week 3 — Gap Analysis
Every finding mapped to its requirement, ranked by risk, impact, and owner, with immediate containment actions separated from systemic fixes. We validate findings with your team so nothing in the report is a surprise.
You receive: the prioritized gap register plus an SOP inventory — what exists, what’s thin, and what’s missing entirely.
Week 4 — Readout & Roadmap
A leadership readout with the prioritized gap register, the sequenced remediation roadmap, and starter templates — plus the honest conversation about what comes first.
You receive: the final gap report, the sequenced remediation (CAPA) roadmap with owners and timeframes, and starter templates your team keeps using — delivered in a live readout call.
WHERE IT APPLIES
One method, five industries.
Cannabis is our home base — the method was built there first. The same evidence discipline serves each industry below, mapped to its own regulations.
Food & Beverage
Preventive controls, supplier verification, environmental monitoring, and traceability under 21 CFR Part 117 and FSMA.
Dietary Supplements
Component qualification, master manufacturing records, and laboratory controls under 21 CFR Part 111.
Cosmetics
Safety substantiation, GMP records, and adverse-event readiness under MoCRA.
Pet Food
Preventive controls for animal food, supplier programs, and sanitation under 21 CFR Part 507.
QUESTIONS
The assessment, answered.
What exactly do we receive at the end?
Three things: a prioritized gap register (every finding ranked by risk, impact, and owner), a sequenced remediation roadmap (what to fix, in what order, before what deadline), and starter templates your team keeps using after we leave.
How much does the assessment cost?
It depends on your facility’s size, complexity, and scope. We agree a fixed fee in the statement of work before starting — no hourly meter, no surprise invoices.
Do you come on-site?
Yes. Week 2 is on-site — two to three days of walkthroughs and interviews at your facility, anywhere in the US. Weeks 1, 3, and 4 run remotely.
Which industries is this for?
Cannabis is our home base, and the assessment serves food & beverage, dietary supplements, cosmetics, and pet food manufacturers too — each mapped to its own regulations. See our food & beverage, supplements, cosmetics, and pet food programs.
What happens after the four weeks?
You own the roadmap and the templates. Some teams execute internally; others bring in targeted help — protocol development, remediation support, or a follow-up verification. Either way, the plan is yours.
Do you guarantee we’ll pass inspection or get certified?
No — and be wary of any consultant who does. We do GMP readiness: we find every gap, rank it by risk, and hand you a sequenced plan to close it, then we can stay and execute it with you. The outcome depends on follow-through, and we’ll tell you honestly where you stand at every step. What we do guarantee: a thorough, evidence-backed assessment, no sugarcoating, and a roadmap your team can actually run.
THE ASSESS → BUILD PATH
Need the full QMS written, not just assessed?
The assessment maps every gap — that’s the Assess step. Our QMS writing engagement is the Build: it creates the actual system — quality manual, SOP library, CAPA, change control — implemented with your team.
FIT CHECK
Is the assessment right for you?
Two honest sentences before you book the call.
Best for
Licensed manufacturers in cannabis, food & beverage, supplements, cosmetics, or pet food with an inspection, audit, or expansion on the horizon — and no honest baseline of where they stand.
Start smaller instead
Earlier in the journey? Take the 3-minute readiness check or download the free 28-point checklist first — then book the call when the gaps start looking real.
Don't let the first gap be found under pressure.
Start with a free fit call — we'll talk through your situation and tell you honestly whether the assessment is the right next step. No pressure, no pitch; the call is free either way.