Wellbeing Digital Sciences Inc. (NEO: MEDI | OTC: KONEF | FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research, announces that its wholly owned subsidiary KGK Sciences Inc. (‘KGK’) provided regulatory guidance and expertise on behalf of its client, Hofseth Biocare ASA (HBC.OL) (‘HBC’ or the ‘Client’), to develop a New Dietary Ingredient (‘NDI’) dossier for notification to the US Food and Drug Administration (the ‘FDA’) for its patented ProGo branded ingredient. FDA has responded with a no objection letter, also called an Acknowledgement (AKL) Without Comment Letter.
HBC, a leading manufacturer and marketer of unique and innovative marine-derived calcium, protein, collagen, and lipid nutritional supplements, is now part of an exclusive short list of companies that have successfully notified FDA of their NDI. The AKL response letter from FDA for ProGo is the highest safety rating and attestation the Client could have received for its dietary ingredient. This achievement follows on the heels of successful receipt of the same accolades for both CalGo and OmeGo late last year. Today, HBC’s entire portfolio of human food-grade ingredients has received FDA’s ‘good day’ AKL Letter.
“KGK has significant experience in helping its clients achieve their goals by earning these high marks of achievement and market distinction and we are thrilled to be able to assist HBC, a valued client of KGK, distinguish themselves from its competitors,” “Consumers and retailers are starting to understand what it means to have an AKL no-objection letter from the FDA. Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods, and rigorously reviewed by FDA scientists,” Najla Guthrie, CEO of Wellbeing and KGK
‘KGK is a leading contract research organization (CRO), offering high-quality clinical research trials and expert regulatory support for the nutraceutical industry,’ said Angelika Florvaag, Chief Quality Officer at HBC. ‘At HBC we pride ourselves in producing superior health ingredients to enhance human health and quality of life, above and beyond what is currently available in the market today and KGK has enabled us to continuously meet that high standard,’ commented Angelika.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
ABOUT HOFSETH BIOCARE
Hofseth BioCare (HBC) is a fully integrated salmon business, devoted to enhancing human nutrition and wellbeing in the most natural, sustainable way. Its naturally safe ingredients deliver pure nutritional performance and clinically-proven health benefits, while conserving the delicate ecological balance. A global leader in marine lipid and peptide research, HBC’s resourceful, tried and trusted, truly sustainable approach to human health is unrivalled. Patent-protected enzymatic hydrolysis technology preserves high-quality lipids, proteins and calcium/collagen, yielding naturally safe ingredients with clinically proven health benefits. For additional information, please visit https://hofsethbiocare.com.