← All services

Productized offerings

Fixed-fee wedge engagements with defined scope and turnaround. Designed to answer a specific question or deliver a specific artifact, and to lead naturally into larger work only if it's actually warranted.

The Contamination Case File

A microbial investigation for cultivators and manufacturers tired of guessing. “Total yeast and mold” and “bile-tolerant gram-negatives” aren’t single organisms — they’re categories covering hundreds of thousands of species. Your failure is usually one or two specific culprits, and they leave evidence. We walk the facility, sequence the isolates to species level, trace the transmission path, and hand you a written case report. Six hours, fixed fee, from walkthrough to findings. The fastest first move when a harvest is failing right now, and the wedge into a full Microbial Root-Cause Investigation only if the problem actually needs one.

EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.

What we deliver

  • ·Facility walkthrough — the full process room by room (moms, veg, flower, dry, cure, trim, package) plus raw materials, inputs, and beneficials, mapping every point microbes could enter
  • ·COA failure review to narrow the likely organism group and flag where in the process it is entering
  • ·Isolate sequencing coordination — species-level identification of what is actually on the product, not a vague TYM/BTGN CFU count or “TNTC”
  • ·Transmission-path analysis tracing the organism back against the facility walkthrough to the most probable entry point
  • ·Live debrief walking through the finished report together and aligning on next steps
  • ·The Case Report — a written 1–2 page summary naming the top suspect organism(s), the likely entry point, and a prioritized action list: what to monitor, what to sample and how often, what root cause to fix — and what not to waste money on

Who leads

Tess Eidem, PhD (PCQI; cannabis microbiology and bioaerosol depth; Senior Research Associate, CU Boulder Environmental Engineering Department).

Bleaching and ozonating everything won’t fix the problem, and neither will remediation — remediation tolling recurs every time you fail again. This finds the source once.

Process Authority Letter (PAL)

Process Authority designation and a signed PAL for finished-product SKUs — required for state filings, particularly cannabis-infused beverages under the California DCC framework (Title 4 Div. 19 CCR).

EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.

What we deliver

  • ·HACCP classification under 21 CFR Part 113, 114, or 120 (LACF / Acidified / Juice), or shelf-stable carbonated-beverage exception
  • ·GRAS and FDA Substances Added to Food review for every ingredient
  • ·Critical-limit calculations for the preservation system (acidulants, antimicrobials, emulsifiers, processing aids)
  • ·Per-SKU spec table, formulation table, and regulatory justification block
  • ·Signed PAL PDF, plus one revision round

Who leads

Andrew Samann (Process Authority of record on multiple state-approved cannabis-infused beverage SKUs) and Tess Eidem, PhD (PCQI under FSMA 21 CFR 117 Subpart C). Both credentialed, both named on the engagement.

The cleaner the data you give us, the lower the engagement cost.

Federal Pathway Readiness Diagnostic

A fixed-fee diagnostic that tells a state-licensed cannabis cultivator whether they are positioned to file under 21 CFR § 1301.13(k) — the 60-day federal-registration window that opened with AG Order 6754-2026. Runs remote-by-default; on-site available if the operator wants facility eyes.

EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.

What we deliver

  • ·Records review across cultivation, post-harvest, storage, security, documentation, training, and quality
  • ·Structured personnel interviews (QA, operations, security) by video
  • ·Facility walk-through — by video for the remote tier, in person for the on-site tier
  • ·Gap Assessment rated against a four-tier rubric — Critical, Major, Minor, Observation
  • ·Project Management Plan proportionate to current state — prioritized remediation roadmap, sequencing, capability needs, recommended follow-on scope
  • ·Closing briefing within 10 business days; written report delivered shortly after

Who leads

Andrew Samann (DEA § 1301.13 framework; ICH Q7 lead-auditor experience; previously led ASTM D37.02 QMS Subcommittee for Cannabis).

If the diagnostic shows you're already in good shape, we tell you that and you save a year of unnecessary consulting work.

Basic Design Qualification (10-hour retainer)

Fixed-fee 10-hour retainer that authors a User Requirements Specification for a proposed facility expansion or build-out, sets the DQ procedure into your QMS, and produces a punch list of open questions plus required engineering inputs. The wedge into a full DQ and commissioning program.

EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.

What we deliver

  • ·User Requirements Specification (URS) — room-by-room, populated from your architectural drawings, with process steps, environmental setpoints, surface finishes, utilities, gowning class, material and personnel access rules, plus a room-zoning matrix
  • ·One-page DQ procedure (PON / SOP) defining the URS → DQ → IQ / OQ / PQ → PV lifecycle and the Quality Risk Management linkage, slotted into your Controlled Documents List
  • ·DQ Punch List and Open Questions document — what work remains, who owns each line, what engineering inputs (HVAC, electrical, plumbing, BMS, security, architectural updates) the client must supply before DQ can close
  • ·Kick-off and scope-confirmation meeting with the QAP and project sponsor
  • ·Explicit out-of-scope list — full QMS rewrite, Validation Master Plan, Environmental Monitoring program, Contamination Control Strategy, HVAC commissioning, IQ / OQ / PQ execution. Each is a candidate follow-on engagement

Who leads

Andrew Samann (EU GMP, ICH Q7 lead auditor experience across 100+ engagements; previously led ASTM D37.02 QMS Subcommittee for Cannabis).

Bounded scope, defensible output. We don't try to rewrite the QMS in 10 hours — we deliver the URS, the DQ procedure stub, and the punch list of what comes next.

Talk to us about an engagement

Send a note describing what you’re working on. We reply directly, from a cofounder. Every engagement is scoped at intake.