KGK Science, a North American contract research organisation (CRO) specialising in nutraceuticals, dietary supplements and consumer health, has announced it has received a growth investment led by Maxim Partners.
The investment, which closed at the end of last month, will support KGK's expansion of clinical trial capacity, continued investment in decentralised and virtual clinical trials and growth of its regulatory and commercial services.
Financial terms were not disclosed.
Founded in 1997 and headquartered in London, Ontario, Canada, KGK Science has completed more than 400 clinical trials across more than 40 health indications and contributed to more than 150 peer-reviewed scientific publications.
The company provides human clinical research, regulatory consulting and claim substantiation services to consumer health companies developing and commercialising products globally.
Raising the bar for health claims
The investment comes as nutraceutical and dietary supplement companies face growing pressure to generate robust evidence supporting product efficacy and health claims.
In the US, FDA guidance states that manufacturers making certain dietary supplement claims must have substantiation that their claims are truthful and not misleading.
The agency recommends that companies consider whether evidence is relevant to the specific product and claim, scientifically sound and adequate in the context of the total body of evidence.
The US Federal Trade Commission (FTC) similarly states that health-related product claims should be supported by competent and reliable scientific evidence.
Its guidance highlights the importance of ensuring that evidence is scientifically sound, adequate and relevant to the specific product and advertising claim.
For nutraceutical brands, this creates demand for specialist clinical research organisations that can help design and conduct human trials, generate product-specific evidence and navigate regulatory requirements around claims.
KGK said the investment will enable it to expand these capabilities as demand grows for clinically validated consumer nutrition products.
"Demand for clinically validated consumer nutrition products continues to grow," said Gregg Wilson, founder and Managing Partner of Maxim Partners.
We believe KGK is exceptionally well positioned to capitalise on those long-term industry trends. We are excited to partner with Najla and the management team to support the company's next phase of growth.
KGK founder and CEO Najla Guthrie and the existing management team will continue to lead the company.
Evidence as a competitive advantage
The deal highlights the growing strategic importance of clinical research and claim substantiation in the nutraceutical sector.
As companies seek to differentiate dietary supplements and consumer health products in an increasingly competitive market, human clinical evidence and regulatory expertise can play an important role in supporting product development, claims and commercialisation.
For KGK Science, the investment is expected to provide additional capacity to support nutraceutical and consumer health companies seeking to develop evidence-backed products for global markets.
