GACP + GMP Gap Assessment (Schedule III posture)
The primary commercial offering for state-licensed cannabis operators in the post-April-2026 federal-pathway environment. A scoped Stage 1 assessment that maps your growing (GACP — good agricultural and collection practices) and manufacturing (GMP — good manufacturing practices) against the standards required by the operator's chosen downstream lane — state-medical-only plus § 1301.13(k) overlay, EU GMP / Annex 7 export, IND/NDA, CTM supply, or pharma partnership. Delivers gap findings, a sequenced remediation roadmap, a CAPA register, and a binding Stage 2 scope recommendation.
EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.
What we deliver
- ·Structured pre-engagement intake (state licenses, controlled documents list, current SOP inventory, recent inspection / audit reports, open CAPAs, GMP equipment inventory, target downstream lane)
- ·Assessment — remote (records, video walkthrough, virtual interviews) or on-site (2–3 days, one cofounder lead plus supporting domain expert covering cultivation, processing, packaging, vault, lab, and warehousing). On-site catches findings that don't surface on paper — gowning discipline, traffic flow, posted-vs-controlled SOP gap, equipment condition.
- ·Gap assessment report — findings categorized by domain and severity tier (Critical / Major / Minor / Observation), each mapped to the specific clause of the target standard (21 CFR 111/117/211, EU GMP Part II + Annex 7 + Annex 1 + Annex 15, ICH Q7, or § 1301.13(k) overlay)
- ·Prioritized remediation roadmap with sequencing dependencies, capability requirements, realistic timelines, and critical-path constraints
- ·CAPA register (working spreadsheet) for client tracking
- ·Binding scope recommendation for any Stage 2 follow-on engagement — fixed-fee or estimated based on assessment findings
- ·Optional 60-minute virtual closing briefing within 10 business days
Who leads
Andrew Samann (overall framework; GMP / cGMP / DEA; ICH Q7 lead-auditor experience at SGS North America; ASTM D37.02 Subcommittee experience). Kate Evans, PhD (cross-domain principal; ANAB and A2LA ISO 17025 lead assessor; ASTM D8493-23). Tess Eidem, PhD (microbiology, GACP, EM; PCQI). Julie Kowalski, PhD (A2LA ISO 17025 lead assessor; analytical chemistry, QC alignment, AOAC CASP Pesticide Think Tank co-chair).
“If the assessment shows you're already in good shape, we tell you that explicitly and you save a year of unnecessary consulting work. If not, the Stage 2 recommendation comes with a real number and a real plan.”
EU GACP + GMP Gap Assessment (Export Readiness)
A scoped Stage 1 assessment for operators targeting EU pharmacy-market export. Maps cultivation (GACP — WHO/EMA HMPC + EudraLex Annex 7) and manufacturing (EU GMP Part I & Part II) against the EU requirements an FDA-baseline operation typically does not yet meet — the Qualified Person batch-certification function, the Annex 1 Contamination Control Strategy, the Site Master File, Annex 15 qualification/validation, and EU GDP for distribution. Delivers gap findings mapped to the specific EudraLex clause, a remediation roadmap with the QP timeline on the critical path, a CAPA register, and a binding Stage 2 recommendation.
EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.
What we deliver
- ·Structured pre-engagement intake — target Member State(s) and importer/QP arrangement, product types and dosage forms, current quality system and Site Master File status, licenses and any EU/EMA or third-country certificates, recent inspection history and open CAPAs, equipment and utilities inventory
- ·Assessment — remote (records, video walkthrough, virtual interviews) or on-site (2–3 days across cultivation, active-substance, finished-product, QC, and warehousing), one cofounder lead plus a supporting domain expert
- ·Gap report mapped clause-by-clause to EudraLex Volume 4 — Part I, Part II (ICH Q7), Chapter 1 (Pharmaceutical Quality System), Chapter 7 (outsourced activities), and the relevant annexes (1 sterile / contamination control, 7 herbal, 11 computerised systems, 15 qualification & validation, 16 QP certification) plus WHO/EMA GACP — severity-tiered Critical / Major / Minor / Observation
- ·Explicit assessment of the EU-specific deltas US-baseline operators miss: Qualified Person function and batch-certification readiness, the Annex 1 Contamination Control Strategy, the Site Master File, the Annex 15 validation lifecycle, written technical/quality agreements, and EU GDP if you distribute
- ·Prioritized remediation roadmap with sequencing dependencies — with the QP engagement timeline (typically 12–18 months) flagged on the critical path so it is started early enough
- ·CAPA register (working spreadsheet) for client tracking
- ·Binding scope recommendation for any Stage 2 follow-on (integrated EU/FDA PQS build), fixed-fee or estimated from the findings
- ·Optional 60-minute virtual closing briefing within 10 business days
Who leads
Andrew Samann (EU GMP and ICH Q7 lead-auditor experience; certified multiple Canadian cannabis Licensed Producers; international compliance against EU GMP and EMA). Kate Evans, PhD (pharmaceutical analysis and cGMP — analytical method development/validation, instrument qualification, FDA test-method submission; ISO 17025 lead assessor). Tess Eidem, PhD (GACP, microbiology, environmental monitoring; PCQI). Julie Kowalski, PhD (analytical method validation, QC alignment).
“We map you against the EU bar and tell you what the Qualified Person will actually require — before you spend on a build that misses it. Readiness, not grant.”
ISO/IEC 17025:2017 Lab Accreditation Readiness
ISO/IEC 17025 is the international standard a testing lab must meet to be accredited — trusted to report results. We build a lab's quality system and test methods to the point of passing its first on-site assessment by its chosen accreditation body (PJLA, ANAB, A2LA, IAS, or other).
EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.
What we deliver
- ·Stage 1 — Business-case confirmation (is 17025 actually the right tool for the goal?), gap assessment report with prioritized remediation backlog, scope-of-accreditation document, dated critical-path plan, one to two days on-site
- ·Stage 2 — Quality manual and procedures (impartiality, confidentiality, structure, data and records control, nonconforming work, decision rules, CAPA, risk), method verification dossiers, ICH Q2 validation dossiers, measurement uncertainty budgets, proficiency-testing enrollment plan, internal audit and management review, remote mock assessment, up to two days remote AB assessment-week support
Who leads
Kate Evans, PhD and Julie Kowalski, PhD (both ISO 17025 lead assessors — assessor-side perspective is the differentiator; Julie also leads analytical-chemistry method validation), Tess Eidem, PhD (microbiology methods), Andrew Samann (QMS and cGMP alignment; ICH Q7 lead-auditor experience at SGS North America).
“Readiness, not grant. We get you ready; the AB awards the certificate.”
International or Greenfield Cannabis Testing Lab Build
Full lab program — facility, methods, QMS, validation, and accreditation readiness — for greenfield cannabis testing labs in markets where the regulatory framework demands EU GMP and ISO 17025 dual compliance from day 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
- ·Phase 1 — Discovery and gap assessment (regulatory landscape, facility room-separation review, equipment inventory, scope-of-test decision, binding SOW)
- ·Phase 2 — Method development and tech transfer (cannabinoids HPLC; pesticides LC-MS/MS and GC-MS/MS; heavy metals ICP-MS; mycotoxins; microbial plating and qPCR; moisture and water activity; terpenes; residual solvents; foreign matter; sample preparation)
- ·Phase 3 — Validation per ISO 17025 Cl. 7.2 and EU GMP Annex 15, measurement uncertainty per EURACHEM/CITAC CG4, robustness, ruggedness, PT sample analysis
- ·Phase 4 — QMS build (ISO 17025 Cl. 8; EU GMP Chapter 4 document architecture; ALCOA+ data integrity; environmental monitoring; OOS and OOT investigation)
- ·Phase 5 — Accreditation readiness — mock pre-assessment, corrective actions, signed competency records per analyst per method
Who leads
All four cofounders. Julie leads analytical chemistry, Tess leads microbiology, Andrew leads QMS architecture, Kate operates as cross-domain principal.
“Co-development. Client staff embedded from day one. The goal is not to develop methods for the client but to develop the client's people through the method development process.”
GMP Facility Design & URS (Architect-Ready Brief)
The first deliverable of a GMP facility build is not a floor plan — it is a document-controlled User Requirements Specification that makes the facility compliant by design. We turn your operation, process, and regulatory targets into a regulation-traceable brief your architect and mechanical engineer can design to. For greenfield builds and, more often, expansions and retrofits. Stops at an approved V1.0 design; flows into the Design Qualification + 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
- ·Regulatory framework hierarchy for the build (e.g., Health Canada GPP + EU GMP EudraLex Vol. 4 Ch. 3 & 5 + Annex 1 contamination-control principles + ICH Q9 risk basis), with a most-stringent-applies rule
- ·Zoning matrix — every room classified (non-GMP / support / open-product / controlled storage / egress), with PPE and access driven by zone, not job role
- ·Unidirectional personnel and material flow — GMP boundary defined, tiered gowning, per-room de-gowning egress, the material-state model, and waste / destruction routes
- ·Engineering envelope — ΔP pressure cascades, HVAC ranges (T / RH / ACPH / filtration), surfaces and finishes (epoxy + coving, washable, no ledges), lighting, drainage, and EM infrastructure
- ·Room-by-room URS with acceptance criteria, plus a consolidated Design Change Recommendations punch list that anchors the architect submission
- ·An approved V1.0 facility design / architect brief — structured so the design can later be formally qualified (DQ)
Who leads
Andrew Samann (URS author; EU GMP and ICH Q7 lead-auditor experience; facility design, design qualification, and commissioning). Tess Eidem, PhD on contamination-control and environmental-monitoring inputs.
“Compliant by design beats remediated later. The URS is the brief you hand your architect — and the document that makes the design qualifiable. Phased and decision-gated: this stage gets you the brief; Design Qualification and commissioning follow.”
Design Qualification + Qualification / Commissioning Program
The phased program that takes a Health-Canada-licensed cannabis facility (or any GMP facility expanding or being built greenfield) from URS draft through to an audit-ready DQ record and Commissioning Master Plan. Built around the nine questions every EU GMP / Annex 1 / Annex 15 auditor will ask on day one of an export-readiness audit.
EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.
What we deliver
- ·Sequence A — Foundation (~11 hours): URS v1.0 finalization plus sign-off, Contamination Control Strategy (CCS) synthesized from existing risk assessments per Annex 1, DQ trace matrix skeleton
- ·Sequence B — DQ close-out (~12 hours, after architect issues V1.0 drawings): DQ trace matrix complete (every URS line item linked to a design verification), training matrix tied to the V1.0 layout, Commissioning Master Plan first issue
- ·Sequence C — Commissioning + qualification (~17 hours, during construction): HVAC IQ + OQ protocols (zoning, ΔP cascade, filter classes, ACPH, recovery times), equipment IQ protocol pack (dryers, trimmers, packaging line, vault), Environmental Monitoring program design + baseline-study protocol
- ·Sequence D — Cleaning validation (~6 hours, when SOPs and equipment are stable): CVMP authoring, 3-batch validation supervised by us and executed by you, residue-limit chemistry partnered with your CRO
Who leads
Andrew Samann (DQ author / reviewer; EU GMP + ICH Q7 lead-auditor experience). Tess Eidem, PhD on CCS and EM program inputs. Julie Kowalski, PhD on equipment IQ analytical-method validation inputs.
“The auditor's nine questions are immutable. The choice is how you're ready, not whether. Each sequence is individually scopable and approvable — you don't commit to the whole program at once.”
Microbial Root-Cause Investigation + Preventive Controls Build
When a facility is failing microbial QC repeatedly — yeast and mold, bile-tolerant gram-negatives, Salmonella, E. coli, Aspergillus, Penicillium — we work the COA data, identify contamination vectors, design environmental monitoring, and (optionally) build a written preventive controls program modeled on FSMA 21 CFR Part 117.
EngagementScoped at intake. Every engagement is sized to the work, so we quote to scope rather than publish a list price.
What we deliver
- ·Stage 1 (remote root cause) — COA review and failure-pattern analysis by room, strain, harvest week, and biological-input timing; root cause hypothesis report with prioritized contamination-vector ranking; environmental monitoring protocol (settle plates, surface swabs, water sampling) with equipment list; sanitation SOP recommendations; coordination with the testing lab for species-level ID
- ·Stage 2 (on-site + preventive controls) — On-site facility evaluation; hazard analysis from cultivation through dry-room; written preventive controls (process, sanitation, supply-chain) Part 117-modeled; corrective-action procedures (hold/test/release); monitoring and verification program with recordkeeping; microbial risk assessment narrative; regulatory positioning summary
Who leads
Tess Eidem, PhD (PCQI; cannabis microbiology and bioaerosol depth) and Andrew Samann (QMS and regulatory framing).
“Begin with Stage 1. Transition to Stage 2 only if remote work does not fully resolve. Most contamination problems are solvable from the data without burning travel hours.”