Dietary Ingredients & Supplements
Pinney Associates brings its renowned expertise in regulatory science, risk and safety evaluation, and health product commercialization to the development of dietary ingredients and supplements. We support your efforts to map the most efficient, cost-effective path toward acceptance of your product by FDA.
EXPLORE OUR SERVICES
Before you submit a New Dietary Ingredient Notification (NDIN), you need supporting safety data that meets regulatory requirements. We prepare your gap analysis and work with you to develop a study plan appropriate to your goals and the product.
- FDA meeting preparation and support
- Marketing support
- Benefit-risk analysis
- Science-based communications
- Submission assistance
Product Development Strategy
We start with your product, helping you identify ingredients with potential therapeutic or consumer health benefits, and advising you on optimal formulation. From there, we design a research program to aid you in defining and supporting your claims and positioning in the market.
- Competitive analysis
- Consumer survey development, data analysis, and reporting
- Labeling and claims development
- Survey vendor identification
Safety Submission Preparation
Defining a product is only the beginning of a New Dietary Ingredient Notification (NDIN). We work with you to develop the regulatory approach and research plan that will meet safety requirements and support FDA acceptance of the labeling and claims you are seeking.
- Due diligence
- Historical use and safety data evaluation
- Partner and vendor identification
- Study and protocol design, planning, coordination, and interpretation