Please complete the sample submission form. New clients will need to include payment and a completed General Terms and Conditions Document with their first submission. Contact us for pricing and turnaround time.
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1. Complete the General Terms and Conditions Document and mail or scan and email the document to 1463 Sand Hill Road, Suite 305, Candler, NC 28715
2. Complete the formulation services request. These questions serve to give us both a picture of our starting point.
3. Submit the formulation services request and enclase a $100 review fee (deposit applied to contract).
4. We will contact you to set up an initial 1/2 hour consultation, during which we will be available to answer your specific questions and to discuss any questions we may have regarding your project.
5. We will then create a customized scope of work for you with cost estimates for each category and deposits required to move forward.
6. If you choose to engage us, we will initiate your custom scope of work.
NDIN Consulting, Authoring and Submission Services
On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law. Among other provisions, DSHEA established the definition of a “new dietary ingredient” (NDI), which is a dietary ingredient that was not marketed in the United States prior to October 15, 1994. Manufacturers or distributors of an NDI, or of a dietary supplement that contains an NDI, must submit a premarket New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before introducing the product into interstate commerce. If a notification is required for a product containing a new dietary ingredient and the product is marketed without the required notification, the product is considered adulterated by law.
USBSL provides NDIN consulting, authoring, and submission services. We have a proven track record of successful NDIN submissions and will work with you every step of the way to ensure FDA compliance of your new dietary ingredient.