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 on the specific clinical trial regulation services we offer for the USA and Canadian market.
We can facilitate new dietary ingredient notifications (NDIN) application, generally recognized as safe (GRAS) application and health claim substantiation.
We help up to conduct natural health (NHP) master file submissions, licensing (compendial and non-compendial), product labelling, finished product specifications and quality summary reports.
Alongside this we offer other regulatory support. Our expert team can advise on probiotic strain characterization, the accurate identification at the strain level, which includes WGS (whole genome sequency) and identification report. Safety assessments can be performed. Bile and pH tolerance using TIM or SHIME can be explored. Finally, phage identification, next gen probiotics, ingredients characterization, operational and supply chain support can be provided.
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.
