Audited consistently. Documentation on request.

Highland operates under multiple overlapping certification frameworks — federal organic compliance, dietary supplement cGMP, kosher and halal certifications, and a continuous program of third-party analytical verification. Audit reports, Certificates of Analysis, and supporting documentation are available to qualifying customers under NDA.

Four standards. Above standard.

◇
USDA Organic
Certified by Quality Assurance International
Audit ID 2024-QAI-NC-1188
Renewed annually
◈
cGMP Certified
Dietary supplement cGMP
21 CFR Part 111 compliant
Annual third-party audit
◊
UHPLC Verified
On-site analytical lab
Compound assay per lot
COA provided with shipment
◉
Kosher & Halal
Star-K certified · Halal certified
Plant-based pipeline
Vegan-compliant throughout

The specifics, for compliance teams.

01
USDA Organic
Highland's cultivation substrate, inoculation media, extraction solvents, and finished extracts are all certified compliant with USDA National Organic Program standards. Annual audit performed by Quality Assurance International (QAI), one of the largest USDA-accredited certifying agents in North America. Certification covers the full chain of custody from raw input to finished extract.
02
cGMP — 21 CFR Part 111
Highland operates under current Good Manufacturing Practices for dietary supplements as defined by FDA Title 21, Part 111 of the Code of Federal Regulations. This covers personnel qualifications, facility design, equipment calibration, production records, quality control, COA generation, complaint handling, and seven-year batch record retention. Annual third-party audit performed by an independent certifying body. Documentation available under NDA.
03
UHPLC compound verification
High-performance liquid chromatography is used in-house to assay every production lot for target compound concentration. Standardization tolerance is ±2% of label claim. Beta-glucans are measured separately by enzymatic assay. Material that does not meet specification does not leave the facility. Independent third-party laboratories cross-verify samples on a randomized cadence; results are filed against the lot record and provided with the Certificate of Analysis.
04
Kosher & Halal
Both Kosher (Star-K) and Halal certifications cover facility operations, equipment, supply chain, and finished product. Highland's production pipeline is plant-based throughout and vegan-compliant. Certifications are renewed annually with on-site inspection. Certification documentation for either program is provided on request to customers serving kosher or halal markets.

What we test for, on every lot.

PANEL · A

Compound concentration

UHPLC quantification of target compounds per species — erinacines and hericenones for Lion's Mane, beta-glucans for Turkey Tail and Reishi, cordycepic acid for Cordyceps. Standardization tolerance ±2% of label claim.

PANEL · B

Heavy metals

ICP-MS quantification of arsenic, cadmium, lead, and mercury against USP <232> and California Proposition 65 limits. Material that exceeds limits is rejected from the batch and does not enter finished inventory.

PANEL · C

Microbial contamination

Total aerobic plate count, yeast and mold, E. coli, Salmonella, and Staphylococcus aureus testing per USP <2021> and <2022>. Results filed against the lot record.

PANEL · D

Residual solvents

Highland's extraction process is aqueous and solvent-free; the air-dry finishing step uses no organic solvents. Every lot is nonetheless screened by gas chromatography against USP <467> Class 1, 2, and 3 limits as a precaution, with expected results at non-detect.

PANEL · E

Pesticide screen

Multi-residue pesticide panel by GC-MS and LC-MS-MS. Tests against the USDA NOP prohibited substances list and EU MRL framework. As an organic facility, Highland's expected result is non-detect across the panel.

PANEL · F

Identity verification

Species identity confirmed by DNA barcoding (ITS region) on incoming raw material and at final QC release. Ensures that every lot of Hericium erinaceus is in fact Hericium erinaceus, not a substituted look-alike species.

◆COA & audit documentation

Documentation available on request.

Certificates of Analysis, third-party audit reports, certification certificates, and lot-traceability records are available to qualifying customers. Procurement and quality teams running formal supplier qualification can request the complete Technical Dossier — quality manual, validated methods, recent COAs, insurance, and corporate setup — under mutual NDA.

Request Tech Sheet → Request Technical Dossier →

Evaluating Highland for your formulation?

We provide samples and full COA documentation to qualifying nutraceutical formulators and supplement manufacturers. No-cost for evaluation.

Request a Sample → Request Tech Sheet →