In the United States of America, dietary supplements are regulated under the Dietary Supplements Health and Education Act (DSHEA), placing supplements under the food umbrella. With DSHEA came a definition for the terms “dietary supplement” and “new dietary ingredient” (NDI) and when a notification is required.
Find out more about different types of claims that be made in the USA regulatory field the specific clinical trial regulation services we offer for the USA and Canadian market.
Atlantia can support you in the GRAS eligibility assessment of your food ingredient and the preparation and filing of your GRAS dossier.
An NDI assessment of your ingredient and the preparation and filing of your dossier is required. We can support you in this.
Nutrient content claims describe the level of a nutrient in in a dietary supplement, using terms such as contains, provides, good source of, high, antioxidant and or they compare the level of a nutrient in a food to that of another food, using terms such as free, low, more, reduced, and lite. Atlantia can help you gain this type of claim.
This substantiation can come in the form of a human clinical study. We can support you in designing the study to support your structure function claim.
Atlantia can support you in your authorized health claim petition to the FDA.
Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. Atlantia can support you in your qualified health claim petition to the FDA.
Atlantia can support regulatory applications for your product and its health applications in the US market.
The different types of health claims mentioned are approved by the FDA. As a world leading CRO with extensive expertise in regulation, we can help you in gaining FDA approval.
Whether its for GRAS, Atlantia can support you in the eligibility assessment of your food ingredient and the preparation and filing of your GRAS dossier.
We can also support you in the NDI assessment of your ingredient and the preparation and filing of your dossier.
Substantiation of a structure/ function claim can come in the form of a human clinical study. We can support you in designing the study to support your structure function claim.
Atlantia can support you in your authorized health claim or qualified health claim petition to the FDA.
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health.
NHPs, often called "complementary" or "alternative" medicines, include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines, probiotics, and other products like amino acids and essential fatty acids. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
To be legally sold in Canada, NHPs must have a product licence, an eight digit Natural Product Number (NPN). The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Atlantia can guide you in the requirements to obtain a NPN and support you in your product licence application.
Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, to obtain a health claim or as a proof of efficacy.
Our regulatory services include ethical submissions and approvals as well as regulatory compliance with global health agencies.
Atlantia offers a proven ability to meet recruitment milestones of healthy, pre-diseased and diseased participants. We have access to populations of all age groups and we are experienced in recruiting populations from 20 to 600 participants per trial on budget, and on time.
Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.
At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.
The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.
Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.
