KGK Science
KGK Science is a privately held Canadian contract research organization founded in 1997 that provides clinical trial design, virtual trial execution, regulatory consulting, and preclinical services to nutraceutical, cannabis, hemp, and psychedelic product companies in North America and Indonesia.
- Company typePrivate
- Founded1997
- HeadquartersLondon, Canada
- Headcount51–100
- GTM typeB2B
- OfferingServices
What KGK Science does
KGK Science Inc. is a privately held Canadian contract research organization (CRO) founded in 1997 and headquartered in London, Ontario. It operates a premium clinical research and regulatory services model targeting nutraceutical, dietary supplement, food ingredient, cannabis, hemp, and psychedelic product companies, with disclosed operations across Canada, the United States, and Indonesia. The company is led by President & CEO Najla Guthrie, with regulatory leadership provided by Chief Regulatory Officer Corey Hilmas (former FDA regulator and co-author of the FDA's NDI draft guidance).
The firm's core product suite is organized into four pillars: Premium Clinical Trials™ (customized end-to-end or modular clinical trial services), Innovative Virtual Trials comprising PRO-VT™ (participant-reported outcomes) and C-VT™ (customized virtual trials with biological sample collection and wearable integration), Expert Regulatory Services spanning NDI notifications, GRAS conclusions, Health Canada PLAs, and regulatory strategy consulting, and Preclinical Studies covering toxicology, genotoxicity, and in vivo efficacy work. Underlying technology includes GCP-trained clinical operations, proprietary trial methodologies (Augmented RCT©), the CNS Vital Signs computerized cognitive testing battery, and the Cognalyzer® EEG-based objective test for cannabis impairment. The firm maintains a 45,000+ participant recruitment database and claims operational experience across 40+ therapeutic indications and hundreds of regulatory projects.
KGK operates as a B2B professional services business, generating revenue through fee-for-service clinical trial projects, regulatory consulting engagements, and preclinical study contracts. Pricing is quote-based and project-specific, reflecting trial scope, duration, sample size, and regulatory pathway; contracts range from short virtual studies to multi-year, multi-trial collaborations with enterprise sponsors (BioNeutra, AIDP, Unigen, Hofseth BioCare) alongside mid-market and startup clients. Go-to-market is direct B2B sales anchored on a website inquiry form and "Request Proposal" CTA, supplemented by thought leadership (white papers, peer-reviewed publications, The Orange Pill Podcast, monthly newsletter, press releases) and a parallel participant recruitment funnel. The company is founder/management-led with no disclosed venture capital or private equity backing.
KGK Science firmographics
Firmographics- Name
- KGK Science
- Legal name
- KGK Science Inc.
- Website
- https://kgkscience.com
- Company type
- Private
- Founded year
- 1997
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- KGK Science is a privately held Canadian contract research organization founded in 1997 that provides clinical trial design, virtual trial execution, regulatory consulting, and preclinical services to nutraceutical, cannabis, hemp, and psychedelic product companies in North America and Indonesia.
- Ownership category
- akta.pro rank
KGK Science industry classification
Industry- Product category
- Contract Research Organization (CRO) Services
- NAICS
- Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Nonclinical Study Management & Regulatory Writing (IND-enabling) (HLAGAFAN)
Keywords
Where KGK Science is headquartered
LocationHeadquarters
- HQ city
- London
- HQ country
- Canada
- HQ region
- North America
Offices4 records
Markets served
KGK Science business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales
Revenue model
- Clinical Trial Services: KGK Science generates revenue by providing fee-for-service clinical trial research projects to nutraceutical, dietary supplement, cannabis, and related companies. Services are project-based, ranging from end-to-end comprehensive trial management to specific research service modules, billed according to scope, duration, and complexity of the study.
- Regulatory Consulting Services: Revenue is generated through regulatory consulting engagements including NDI notifications, GRAS conclusions, Health Canada Product License Applications (PLAs), regulatory status reviews, gap assessments, toxicology reviews, SOP creation, label reviews, and pharmacovigilance services. These are billed as discrete consulting projects or retainer engagements.
- Preclinical Studies: Fees for preclinical safety and efficacy studies including genotoxicity batteries, LD50 testing, repeat-dose toxicity studies, reproductive toxicology, ADME/PK studies, neurobehavioral studies, and in vivo animal efficacy models.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Participant compensation varies by study type and duration |
| Other | Multi-year contract | B2B service pricing is quote-based and project-specific |
Distribution channels2 records
Marketing channels7 records
KGK Science product offering
Product offeringCore offering
KGK Science is a premium contract research organization that designs and runs customized clinical trials (including virtual PRO-VT™ and C-VT™ formats) for nutraceutical, dietary supplement, cannabis, hemp, and psychedelic product companies. It also provides comprehensive regulatory consulting (NDI notifications, GRAS conclusions, Health Canada Product License Applications, FDA 30-day structure-function submissions) and preclinical safety/efficacy testing. Services are available end-to-end or as scoped modules, with every project supported by GCP-trained clinical research staff and validated cognitive/biomarker assessment tools.
Product overview
KGK Science operates as a premium Contract Research Organization (CRO) offering a comprehensive suite of clinical research and regulatory services for the nutraceutical, cannabis, hemp, and psychedelic industries. The core offerings include Premium Clinical Trials™ (end-to-end or specific clinical trial services), Innovative Virtual Trials comprising PRO-VT™ (participant-reported outcomes virtual trials) and C-VT™ (customized virtual trials), Expert Regulatory Services (NDI notifications, GRAS conclusions, Health Canada PLA submissions), and Preclinical Studies (toxicology and animal efficacy studies). The company also recruits participants for various health studies including cognitive health, women's health, gut health, stress/anxiety, diabetes/blood sugar, sleep, hydration, and pediatric studies.
Differentiator
Problem solved
Functional benefit
Products and services
- Premium Clinical Trials™ High-quality clinical trial research services offering customized trial design to enhance marketing claims, develop intellectual property, and distinguish brands. Provides end-to-end trial services or specific research services for nutraceutical, dietary supplement, cannabis, hemp, and psychedelic industry sponsors.
- PRO-VT™ (Participant Reported Outcomes Virtual Trials) Cost-effective virtual trial solution for nutraceutical validation using participant-reported outcomes, supporting sample sizes of 250, 500, or more participants. Meets HIPAA and 21 CFR Part 11 compliance, with optional Consumer Report Card and rapid executive reporting, designed for swift validation of dietary supplement efficacy claims.
- C-VT™ (Customized Virtual Trials) Remote clinical trials with rigorous, customized design meeting regulatory standards. Offers options for biological sample collection, wearable data devices, and hybrid in-clinic/virtual study models. Supports large sample sizes and expanded scope for diverse study needs among dietary supplement sponsors.
- Expert Regulatory Services Comprehensive regulatory support services including NDI notifications, GRAS conclusions, Health Canada product license applications (PLAs), regulatory status reviews, gap assessments, toxicology reviews, SOP creation, label reviews, and pharmacovigilance. Led by a former FDA regulator, supporting nutraceutical, cannabis, hemp, and psychedelic industry sponsors in FDA, Health Canada, and EFSA pathways.
- Preclinical Studies Preclinical safety and efficacy testing services including genotoxicity batteries, LD50 testing, repeat-dose toxicity studies, reproductive toxicology, ADME/PK studies, neurobehavioral studies, and in vivo animal efficacy models. Supports nutraceutical, food ingredient, and related product development by providing regulatory-grade preclinical evidence to support downstream clinical and regulatory submissions.
Quantifiable outcome
- Successfully completed hundreds of regulatory projects including NDI notifications, GRAS conclusions, and Health Canada PLAs
- +5 more outcomes
Companies that use KGK Science
Customer profileNamed customers9 records
Segments5 records
Ideal customer profiles4 records
KGK Science technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
KGK Science partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- Unigen Inc.coreKGK Science conducted a randomized, triple-blind, placebo-controlled clinical trial for Unigen evaluating Maizinol® on sleep quality. Results were published in the peer-reviewed journal Food Science & Nutrition, and significant findings were presented at Sleep 2025 and Nutrition 2025 conferences. This represents a multi-trial collaboration with publication outcomes.
- Cata-KorcoreKGK Science entered a research services agreement to conduct a human clinical trial evaluating NAD+ Advanced, Cata-Kor's high-dose NAD+ nutraceutical ingredient, supporting the company's product development and regulatory pathway.
- Lucid PsycheceuticalscoreKGK Science successfully secured a Health Canada Class III Product License Application (PLA) for Qlarity™, supporting Lucid Psycheceuticals' successful path to market in Canada as a natural health product.
- WELLEX / Natural Products CanadacoreHealth Canada approved a human clinical trial for Papillex®, a natural cervical health supplement developed by WELLEX in collaboration with Natural Products Canada, with KGK Science providing clinical trial services.
- ATMA CENAminorKGK Science is collaborating with ATMA CENA on a clinical study investigating psilocybin-assisted therapy for Major Depressive Disorder in healthcare workers who worked during the COVID-19 pandemic.
Scale indicators6 records
Recent moves6 records
Expansion highlights5 records
KGK Science competitors and assessment
Company assessmentEmerging players
- Citranex Labs: Citranex Labs is a smaller contract research and testing provider for nutraceutical and food ingredient companies, an emerging player that overlaps with KGK's trial design and regulatory support offerings at a more limited scale.
- Inotiv: Inotiv is a preclinical CRO with toxicology and animal model capabilities comparable to KGK's Preclinical Studies service (genotoxicity, ADME/PK, neurobehavioral, in vivo efficacy), although Inotiv is broader and pharma-oriented.
Broad incumbents
- SGS: SGS is a global testing, inspection, and certification company that supports food ingredient and nutraceutical companies with testing and regulatory services, serving as a broad incumbent comparable in end markets if not in trial management.
- Eurofins Scientific: Eurofins is a global testing and CRO conglomerate with broad food, supplement, and pharmaceutical laboratory services; it is a broad incumbent offering overlapping capabilities (testing, regulatory) but as part of a much wider portfolio rather than a nutraceutical specialty.
- Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-to-large CRO with clinical and bioanalytical services; it is a broad incumbent relevant for sponsors considering scaling beyond KGK's nutraceutical specialty into general clinical development.
- Intertek: Intertek provides testing, inspection, and certification services including for food, dietary supplements, and pharmaceuticals, making it a broad incumbent that touches KGK's regulatory and quality service space but is not nutraceutical-trial focused.
- Pharmaron: Pharmaron is a global CRO/CDMO with preclinical, clinical, and regulatory services; it represents a broad incumbent competitor for KGK's preclinical and regulatory work, particularly for sponsors seeking end-to-end development support.
- Charles River Laboratories: Charles River Laboratories is a major CRO with preclinical and clinical services; it is a broad incumbent relevant because KGK's preclinical service line and clinical operations compete for similar sponsor relationships, even though Charles River is much larger and more pharma-focused.
Direct peers
- CliniGlobal: CliniGlobal is a nutraceutical-focused CRO offering clinical trial management and regulatory support for dietary supplement and food ingredient companies, overlapping with KGK's Premium Clinical Trials™ and Expert Regulatory Services lines.
- Vedic Lifesciences: Vedic Lifesciences is a contract research organization that runs clinical trials specifically for nutraceutical, dietary supplement, and functional food companies — directly comparable to KGK Science's core service offering and target sponsor base.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
KGK Science social profiles
Digital presenceKGK Science financial estimates
Financial estimateRevenue estimate
Valuation estimate
KGK Science leadership team
Management profileNumber of profiles
Profiles3 records
KGK Science funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
KGK Science M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about KGK Science
What does KGK Science do?
KGK Science is a premium contract research organization that designs and runs customized clinical trials (including virtual PRO-VT™ and C-VT™ formats) for nutraceutical, dietary supplement, cannabis, hemp, and psychedelic product companies. It also provides comprehensive regulatory consulting (NDI notifications, GRAS conclusions, Health Canada Product License Applications, FDA 30-day structure-function submissions) and preclinical safety/efficacy testing. Services are available end-to-end or as scoped modules, with every project supported by GCP-trained clinical research staff and validated cognitive/biomarker assessment tools.
Is KGK Science a public or private company?
KGK Science is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was KGK Science founded?
KGK Science was founded in 1997. It employs 51 to 100 people.
Where is KGK Science based?
KGK Science is headquartered in London, Canada, in the North America region.
How does KGK Science make money?
Three revenue lines are on record. Clinical Trial Services are the primary driver. The others are regulatory Consulting Services and preclinical Studies.
Who are KGK Science's main competitors?
Emerging players on record are Citranex Labs and Inotiv. Broad incumbents are SGS, Eurofins Scientific, Worldwide Clinical Trials, Intertek, Pharmaron and Charles River Laboratories. Direct peers are CliniGlobal and Vedic Lifesciences.
Does KGK Science have an API?
No public API is recorded for KGK Science.
What industry is KGK Science in?
KGK Science's product category is Contract Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAFAN, Nonclinical Study Management & Regulatory Writing (IND-enabling). Its NAICS code is 5417 and its SIC code is 8731.