Note that as of October 19, 2019, notifications are not being accepted via the FURLS portal. All notifications are not submitted in COSM. So, submitting notifications (timeframe, format, and method submission) is complex. The occurrence of misinterpreting the Regulatory requirements will result in a product recall. When you partner with us, we will help you:
- Ensure whether your ingredient is a New Dietary Ingredient
- Analyze documentation gap and point out if any other data required
- Complete a full dossier for a New Dietary Ingredient Notification (NDIN)
- Prepare and request an FDA pre-submission meeting
Apart from these, our experts will also help you understand NDIN: Process, Approval and Timeline. You will be able to meet Notification to the FDA and submission requirements, understand the timeline and know the documents to be submitted, be familiar with the submission modes and Post-submission NDIN process.