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.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.