Clinical Trial Regulation USA
Dietary Supplement Regulation
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.
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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.
Our Clinical Trial Process
01. Clinical Design
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.
02. Trial Regulation
Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of the sponsor company to provide highly compliant study design.
03. Study Recruitment
Atlantia offers a proven ability to meet recruitment milestones. 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.
04. Study Conduct
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.
05. Trial Analysis
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.
06. Study Reporting
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.
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.
Media & Resources
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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.Read More
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