Substantiation Sciences provides all aspects of scientific support for substantiating an ingredient or finished product as related to:
1. Product Concept
2. Product Design
3. Ingredient Evaluation
4. Ingredient Selection
5. Independent Evaluation of each Ingredient for DSHEA compliance, dose, historical use, and published scientific support and for intended use
6. Evaluation of your current level of support for marketing claims
7. Scientific and Legal review of product/ingredient and proposed claims (“CARSE” review)
8. Creation of a Product (or ingredient) specific Dossier (Product Master File)
9. Clinical Research Activities – assist you in partnering with appropriate independent researchers (CRO's or Universities) for a variety of clinical studies or projects that may be utilized for new Intellectual Property (patents, Trademarks, "know-how", etc.) as well as for claims substantiation.
10. Study Design (animal, human, laboratory, omnibus)
11. Study Interpretation and Applicability for your market and or goals
12. Medical Writing – assist you in getting data and information published in scientific peer-reviewed journals
13. Technical Writing – White Papers for Industry
14. Market analysis – your competitive land mapping with SWOT analysis
15. GRAS and Self-Affirmed GRAS (Generally Regarded as Safe)
16. Regulatory Compliance- FTC, FDA, NAD, Law Firms, State Attorney Generals, etc.
If there is a service or need that you have and do not see listed here on our Services page, please contact us and let us review with you if we can be of assistance, as our goal always is to do what is best and right for the client.