EAS can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts in toxicology, radiology, chemistry and biology and authorities in government laws and regulations, EAS’ consultants can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.
- Ingredient Premarket Approval and Color Additive Petitions: EAS can work with your company to prepare and submit color additive petitions as well as compile toxicology reports and studies to determine ingredient safety, or design clinical studies to document ingredient safety and substantiate label claims.
- Colors for FDA Certification: Color additives are subject to FDA approval, and in some cases, each batch must be certified by the FDA, before they may be used in products that come in contact with the bodies of people or animals for a significant period of time. EAS offers submission services for firms manufacturing dyes for all FDA regulated products.