KGK Science
KGK Science has been delivering top-notch clinical research trials and expert regulatory support for the nutraceutical, cannabis, hemp, and psychedelic industries for over 27 years. They support companies in bringing their products to global markets with custom trials and claim substantiation strategies, focusing on scientific excellence, regulatory compliance, and innovative research. Their mission is to be the most trusted CRO in these industries, providing evidence-based solutions to help clients succeed in market entry and product development. They also specialize in designing and executing clinical trials, developing protocols, managing regulatory submissions, recruiting participants, conducting studies, ensuring quality assurance, analyzing data, and supporting publication efforts. Additionally, they are involved in research on dietary supplements, probiotics, CBD, and other natural health products, with a focus on regulatory considerations, efficacy, and safety.
Industries
Nr. of Employees
medium (51-250)
KGK Science
London, Ontario, Canada, North America
Products
UP446
A formulation containing Acacia catechu and Scutellaria baicalensis designed to support immune function in response to influenza vaccination in healthy adults.
UP446
A formulation containing Acacia catechu and Scutellaria baicalensis designed to support immune function in response to influenza vaccination in healthy adults.
Services
Full-service clinical trial planning and execution including protocol/IB development, regulatory and ethics submissions, site operations, recruitment support, GCP-compliant monitoring, validated EDC data capture, biostatistics, and comprehensive final reports suitable for regulators.
Remote and hybrid trial execution using PROs, remote sample collection, wearable data, and validated eClinical systems to generate cost-effective and regulatory-grade evidence.
Targeted recruitment strategy development and execution leveraging a staffed recruitment center, digital and traditional advertising, screening, scheduling, and database management to expedite enrollment.
Consulting and dossier preparation for regulatory pathways, product registrations, e-portal submissions, label and claim reviews, and direct regulator engagement to obtain product approvals (including documented Health Canada NHP licence support).
Design and execution of GLP-style preclinical study programs, genotoxicity testing, repeat-dose toxicity studies, reproductive and carcinogenicity assessments, and in vivo efficacy models to generate safety data for submissions.
Remote pharmacovigilance operations offering SAE intake, triage, follow-up, periodic safety reporting, and safety database maintenance for marketed products and ongoing clinical studies.
Full-service clinical trial planning and execution including protocol/IB development, regulatory and ethics submissions, site operations, recruitment support, GCP-compliant monitoring, validated EDC data capture, biostatistics, and comprehensive final reports suitable for regulators.
Remote and hybrid trial execution using PROs, remote sample collection, wearable data, and validated eClinical systems to generate cost-effective and regulatory-grade evidence.
Targeted recruitment strategy development and execution leveraging a staffed recruitment center, digital and traditional advertising, screening, scheduling, and database management to expedite enrollment.
Consulting and dossier preparation for regulatory pathways, product registrations, e-portal submissions, label and claim reviews, and direct regulator engagement to obtain product approvals (including documented Health Canada NHP licence support).
Design and execution of GLP-style preclinical study programs, genotoxicity testing, repeat-dose toxicity studies, reproductive and carcinogenicity assessments, and in vivo efficacy models to generate safety data for submissions.
Remote pharmacovigilance operations offering SAE intake, triage, follow-up, periodic safety reporting, and safety database maintenance for marketed products and ongoing clinical studies.
Expertise Areas
- Clinical trial management and operations
- Virtual, decentralized and hybrid trials
- Clinical outcome assessment and patient-reported outcomes (PROs)
- Regulatory strategy, submissions and compliance (NDI, GRAS, NHP/NHP licence, PLAs, NSN)
Key Technologies
- Standardized patient-reported outcome instruments (PROs)
- 21 CFR Part 11 and HIPAA-compliant electronic clinical systems
- Wearable device integration and actigraphy
- Multi-channel EEG including remote EEG capability
News & Updates
WELLEX, in collaboration with Natural Products Canada, received approval from Health Canada to proceed with a clinical trial on its product Papillex®, supporting women's health with evidence-based natural health products.
A study to determine if a single dose of Apple Cider vinegar has a postprandial glucose effect on those with metabolic syndrome after eating a standardized carbohydrate load.
An article discussing the history and current state of dietary supplement regulation, providing guidance for companies on compliance and market success.
WELLEX, in collaboration with Natural Products Canada, received approval from Health Canada to proceed with a clinical trial on its product Papillex®, supporting women's health with evidence-based natural health products.
A study to determine if a single dose of Apple Cider vinegar has a postprandial glucose effect on those with metabolic syndrome after eating a standardized carbohydrate load.
An article discussing the history and current state of dietary supplement regulation, providing guidance for companies on compliance and market success.