For Raw Material Ingredients
Knowing what your product contains and ensuring label claims are met is not only good business – it is a fundamental regulatory requirement, which starts with Specifications. We provide the most meaningful guidance for establishing raw material and finished product specifications.
One of the tools we created to enable customers to ensure consistency and integrity of their products when working with contract vendors, is the Ingredient Data Sheet (IDS). An IDS is a controlled document that defines various characteristics of a raw material for use in conjunction with a Manufacturer, to better manage the sourcing practice of the material(s) to be used in production. Why is this important? Contract Manufacturers and Private Label Manufacturers are legally allowed to interchange ingredients from different suppliers during the course of production run or between campaigns in order to optimize their production and profitability without notice to their customers, unless a Quality Agreement and appropriately defined IDS are in place. This can directly impact the consistency of quality of your finished product over time and/or between vendors.
New Dietary Ingredient
Do you know if what ingredient you have is a New Dietary Ingredient (NDI) that requires notification to the FDA or not? Or is it an Old Dietary Ingredient (ODI)? We can assist in the review, preparation and electronic submission of New Dietary Ingredients with greater success. Typical submission times frames are 4 to 6 weeks.
Generally Recognized as Safe
For a Self-affirmed GRAS Notifications and use of an Expert Panel to review, or for intended Notification to the FDA, we can assist with the development, management and submission of GRAS dossiers, from start to finish.
For Finished Products
During or after production, manufacturers must assess the consistency and quality of those finished products as required by the FDA or other respective governing agency. This is accomplished with the use of finished product specifications as defined and managed by the respective manufacturer. Regardless of the dosage form of the finished product and industry, there are critical characteristics or parameters that must be identified and controlled for and for the businesses contracting out the manufacturing or co-packing of their products to such vendors, additional regulatory requirements apply. We created the Formulation Data Sheet (FDS) for use by end-customers, as a controlled document help ensure GMP compliance and alleviate unplanned changes to label claims, specifications and even testing methods.