Quality, compliance & substantiation: It all comes naturally at Gnosis
At Gnosis, we believe that world-class nutritional ingredients are defined by more than just a microbial strain or molecular structure. We understand that trust, safety, and compliance are all foundational aspects of nutrition R&D, and we aim to integrate these principles into every workflow step with the same passion and enthusiasm we feel for foundational research and human dietary health.
Regulatory compliance in nutrition: Our experience, your success
While navigating regulatory compliance is a fundamental requirement in nutrition R&D, regional variations and evolving global standards can create bottlenecks that risk commercial success.
At Gnosis, we provide the practical expertise of a partner who’s walked this path before. With a portfolio of globally recognized brands – including MenaQ7®, ibSium® and MyCondro™ – we’ve refined our understanding of various compliance systems, positioning our products to achieve premium and unique access to a variety of diverse markets.
Access your competitive advantage
Ensure regulatory compliance is your gateway to market access – not a limiting factor. By partnering with Gnosis, you can integrate the latest Quality Assurance (QA) and Quality Control (QC) standards throughout your development workflow with ease and precise control. You can even reduce the cost of ownership of in-house resources.
Navigate global and regional networks
Manage the disparate requirements of global regulatory bodies, such as the FDA, EFSA, MHCA, AIFA, ANVISA, TGA, SwissMedic, and EMA, using our blueprint for success. Our experience in navigating these global and regional regulatory networks means we know what to expect – even when designing new products for new markets. Having successfully navigated these agencies to launch our own portfolio, we can provide a proven pathway supported by the right data, medical affairs, and substantiation pipelines.
Gain knowledge and fermented product expertise
Fermentation presents unique biological and regulatory challenges. Our experience in microbial strain characterization can help you establish the genetic and functional profiles of your ingredients to ensure long-term viability and stability across the manufacturing and sales lifecycle. In addition, our metabolic purity and stability testing approaches can help you optimize yield, guarantee bioactive stability, and inform product design for further formulation and packaging.
Compliance is your opportunity for innovation
At Gnosis, we understand that compliance is not just a technical hurdle – it’s the bridge between a visionary concept and a successful brand. Moreover, it’s your opportunity for innovation.
Our experience allows us to identify and leverage circular opportunities – even before they arise. In fact, by anticipating strategic opportunities and challenges in product development, we can help you navigate appropriate medical affairs and scientific substantiation while furthering your intellectual property (IP) portfolio and de-risking complex launches.
We balance careful ethical considerations with precise market insights to ensure the highest standards while optimising flexibility. This allows us to support bespoke and compliant market access while providing you with a blank canvas upon which to bring your vision to life.
We meet pharmaceutical-grade standards
We adhere to stricter pharmaceutical-grade Good Manufacturing Practice (GMP) guidelines in all of our ingredient workflows. This means that our products are ready for even the most stringent regulatory dossiers, clinical trials, and substantiation steps. These are standards that set us apart when it comes to your competitive advantage.
We only use recognized quality management systems (QMS)
Our systems are certified as International Organization for Standardization (ISO) and Hazard Analysis and Critical Control Point (HACCP) compliant. This helps us to ensure consistency, IP safeguarding, and production scalability while providing irrefutable traceability and mitigating recall risks.
We’re market-ready when it comes to food safety
We are already validated according to Generally Recognized as Safe (GRAS) guidelines by the US Food and Drug Administration (FDA), and we’re recognized by the Agenzia Italiana del Farmaco (AIFA) and the Therapeutic Goods Administration (TGA) in Europe and Australia. This means fewer bottlenecks and pre-market approvals when partnering with us—our systems are already in place at no additional cost to you.
We’re certified, ethical, and emotionally resonant with your perfect customer
Our Non-GMO, Halal, Kosher, and Vegan-friendly certifications help us ensure your products and pipelines are as inclusive as they are efficacious. We can help you balance a complete roster of these certifications with science-backed labelling claims, ensuring your product is ready to represent your brand. We’re also Ecological Certification (ECOCERT) certified and prepared for the latest sustainability practices that our industry demands.
Quality in practice means confidence at every step
Whether we’re working to refine and develop our own products or supporting you to successfully launch yours, we apply the same rigorous QA and QC steps. These aspects draw upon our specific fermentation, biotransformation, and biocatalysis expertise.
Explore sensory evaluation
Conduct comprehensive sensory testing (9-point hedonic analyses, Just-About-Right testing, and detailed descriptive analyses) with us as your experienced partner. We can ensure that both fermented and non-fermented products align with consumer preferences and meet the highest standards, while validating that these standards are consistent from batch to batch.
Undertake microbiological analysis
Let us help you integrate rigorous microbial testing to ensure product safety, purity, and shelf-life longevity. This includes raw material QC, starter culture verification, pathogen and process monitoring, and even genetic analyses to evaluate ecological drift. We can also help you ensure, where applicable, that probiotic and prebiotic products are validated scientifically and deliver on the health claims we agree on as a team.
Achieve comprehensive nutritional profiling
We can conduct nutritional analyses to determine the precise bioactive and non-bioactive benefits of products on your behalf. Backed by world-class scientific research, we also support the validation of new and emerging ideas to help you access new markets and showcase consumer benefits with confidence and pride. Our expertise in biotransformation and biocatalysis can help you navigate the complexities of nutritional enrichment.
We substantiate and validate, from lab to label
Scientific substantiation and clinical validation are core priorities at Gnosis. They help us and our partners understand each product’s benefits while building consumer trust through irrefutable proof, accurate labelling, and regulatory compliance. We achieve substantiation and validation through our advanced in-house knowledge base and the wealth of expertise within our networks, both internally and externally to our organization.
Our internal substantiation pipelines inform, advance, and de-risk production
We consider scientific substantiation to be an essential part of our triple-arm approach to product quality and regulatory success. By executing substantiation and validation checks alongside our medical affairs and regulatory dossier preparation pipelines, we ensure that your product development workflows – and our own – evolve with the highest standards and the lowest possible level of risk in mind.
We use substantiation data to:
- Discover new scientific directions and production methodology options.
- Explore marketing needs and provide health-benefit evidence.
- Highlight regulatory needs, avoid potential bottlenecks while turning prospective challenges into new commercial opportunities.
We don’t just provide and interpret pipeline data either; we also anchor our work in established literature and organizes batch production processes to execute our own clinical trials. As scientific communication specialists, we can contribute to the writing of technical content – including scientific articles for publication in peer-reviewed journals, for marketing literature, and for strategic communications that drive your business forward. We are there for you, from first principles to impact.
We’re trusted by world-leading researchers
Our relationships with influential associations and organizations, including the Gut Microbiota For Health (GMFH), the International Probiotics Association (IPA), and the French Gut, compound our trusted position amongst world-leading scientific networks, while providing access to cutting-edge technical expertise. In addition, we are active collaborators in the sponsorship and leadership of numerous clinical trials globally.
We leverage this network of expertise to support you in co-development projects and facilitate access to key opinion leaders in your scientific niche. Partnering with Gnosis grants you the value of world-leading minds without the need to expand your in-house workforce or workspace footprint.
Our strengths and capabilities
Supply chain & customer service
At Gnosis, we pride ourselves on placing the highest value on our partnerships. We go beyond simple supply and workflow management, acting as a strategic extension of your team and a collaborator with specific expertise. Our dedicated Customer Service and Supply Chain teams are always on hand to support you throughout the development lifecycle.
R&D & scientific excellence
Science and discovery are among our core principles and values at Gnosis. Our commitment to innovation underpins everything that we do, and our expert Scientific teams are on hand to ensure you’re fully supported throughout medical affairs and scientific substantiation pipelines.
Quality production & processes
As experts in microbial biotransformation and fermentation technologies, our facilities are equipped to handle even the most complex of requirements to the highest quality standard. Our industrial-scale operations are supported by an extensive in-house scientific package that ensures precision engineering from strain to solution – and beyond to impact.
Partner with us and turn regulatory complexity into your competitive advantage.
Frequently asked questions:
Q: How does Gnosis support Novel Food or GRAS submissions?
A: At Gnosis, we provide comprehensive regulatory support throughout the preparation and submission of regulatory dossiers – including those for European Food Standards Agency (Novel Food) and US Food & Drug Administration (GRAS) compliant products. We work with our partners to create clear submission pathways and to reduce the risk of administrative delays, ensuring that all the materials required (clinical validation and scientific substantiation) are ready and in place for success.
Q: What standards do the Gnosis facilities meet?
A: Our flagship site in Pisticci, Italy, is pharmaceutical-grade compliant and operates under the most stringent international benchmarks. It is subject to rigorous oversight by AIFA (the Italian Medicines Agency), and the facility also conforms to ISO 9001:2015 standards. It maintains certifications for Halal, Kosher, Vegan, Non-GMO, and ECOCERT compliance, ensuring any product produced on site is manufactured to the highest global quality and inclusivity standards.
Q: Who must adhere to GMP guidelines?
A: While basic Good Manufacturing Practices (GMP) are required for all food and supplement producers, we adhere to more stringent Pharmaceutical-grade GMP regulations. This higher standard allows us to ensure batch-to-batch consistency, clinical trial readiness, and the highest level of microbial purity – these standards set us apart when it comes to supporting your brand’s integrity.
Q: Can Gnosis help with the substantiation of dietary health claims?
A: The substantiation of dietary and health claims through scientific and clinical validation is a core innovation philosophy at Gnosis. We support the validation of health claims through the generation of robust scientific data, including metabolic profiling and human clinical trials. Our medical affairs and R&D teams will collaborate with you to ensure that your claims are substantiated, legally sound, and emotionally resonant with your target market.