Industries

Industries we serve.

Five sectors, in order of where the cofounders’ combined experience runs deepest. Each section maps the regulatory frameworks we work in, the engagements that show up most often, and which cofounders carry the bench depth for that industry.

Industry 1

Cannabis

The heaviest weighting of cofounder experience across the firm. State-licensed cultivators, processors, testing labs, infused-beverage operators, and operators on the federal pathway opened by the April 2026 rescheduling.

Regulatory frameworks we work in

21 CFR § 1301.13(k) (DEA registration)AG Order 6754-2026 (Schedule III)21 CFR Part 211 (cGMP)EU-GMP Part II + Annex 7 (export)ISO/IEC 17025:2017 (testing labs)FSMA 21 CFR Part 117 (preventive controls modeled)California DCC Title 4 Div. 19 CCR (cannabis beverages)State medical / adult-use frameworks

Common engagements

Bench depth

All four cofounders. Andrew leads GMP, DEA framework, QMS, and Process Authority work. Kate brings ANAB and A2LA assessor-side experience plus ASTM D8493-23 Technical Contact (cannabis/hemp sample prep). Julie leads analytical-chemistry method validation (cannabinoids, pesticides, residual solvents). Tess leads microbiology, environmental monitoring, and cannabis bioaerosol work.

Industry 2

Hemp

Often paired with cannabis-side work since the regulatory bridge between the two is shifting — particularly with the November 12, 2026 federal hemp-definition change to total THC. Testing labs, ingredient suppliers, and finished-product manufacturers.

Regulatory frameworks we work in

7 U.S.C. § 1639o (hemp definition, current and post-November 2026)21 CFR Part 111 (dietary supplements cGMP)ASTM D8493-23 (cannabis/hemp sample prep)State-by-state hemp programsUSP cannabinoid analytical chapters

Common engagements

Bench depth

Kate is the Technical Contact on ASTM D8493-23 — the standard guide for cannabis and hemp inflorescence sample preparation. Julie's cannabinoid and pesticide method-development experience transfers directly. Andrew on QMS and regulatory framing. Tess on micro QC.

Industry 3

Food & Beverage

FSMA-aligned operations, fermented and functional foods, and beverage Process Authority work. Often appears at the intersection of cannabis (infused beverages under California DCC) and food regulation.

Regulatory frameworks we work in

FSMA / 21 CFR Part 117 (preventive controls for human food)21 CFR Parts 113 & 114 (LACF / Acidified Foods)21 CFR Part 120 (Juice HACCP)PCQI training under FSPCAGRAS / FDA Substances Added to Food reviewCalifornia DCC Title 4 Div. 19 CCR (cannabis-infused beverages)

Common engagements

Bench depth

Tess is a Preventive Controls Qualified Individual (PCQI) under FSMA 21 CFR Part 117 Subpart C, with hands-on fermented-foods business background. Andrew brings FSMA gap-assessment and food-GMP experience from prior engagements. Dual-named Process Authority team on cannabis-infused beverage SKUs.

Industry 4

Pharmaceutical (Rx & OTC)

Pharmaceutical contract manufacturers (CMOs), Rx and OTC topical and oral manufacturers, and operators pursuing the pharma pathway for cannabis (IND/NDA-track, EU pharmacy export, FDA-approved drug product partnership).

Regulatory frameworks we work in

21 CFR Parts 210 & 211 (cGMP for finished pharmaceuticals)EudraLex Vol. 4 Parts I & II + Annexes 1, 11, 15, 16ICH Q7, Q8(R2), Q9(R1), Q10, Q11, Q1221 CFR Part 11 (electronic records / CSV)USP <1058>, <1225>, <1226>ISO/IEC 17025 (Rx/OTC labs)

Common engagements

Bench depth

Andrew on cGMP, regulatory affairs, QMS architecture, and ICH stack (Q7 lead-auditor experience). Kate on pharmaceutical-analysis test method submission to FDA, ICH Q2 method validation, and instrumentation qualification. Julie on chromatography (GC, GC-MS, LC, LC-MS/MS) method development and validation. Tess on micro methods and environmental monitoring.

Industry 5

Dietary Supplements

21 CFR Part 111 cGMP for supplements, analytical method validation for botanical and synthetic ingredients, and the regulatory edge cases where the line between supplement and OTC drug matters.

Regulatory frameworks we work in

21 CFR Part 111 (cGMP for dietary supplements)21 CFR Part 117 (preventive controls)FDA monograph + drug-supplement boundary determinationUSP analytical chaptersICH Q2 method validation

Common engagements

Bench depth

Crossover team — supplement work draws on the same analytical-chemistry (Julie), microbiology (Tess), pharma analysis (Kate), and GMP framing (Andrew) that drive the cannabis and pharma practices. Most supplement engagements are scoped as method-validation or EM program builds rather than full QMS rewrites.

Don’t see your industry?

Cofounder expertise spans broader than five sectors. If you work in personal care, cosmetic-drug boundary products, agricultural chemistry, or an industry adjacent to these — send a note. We’ll tell you honestly whether your work fits how we engage.