Dietary Supplement Regulatory Services
Providing scientific and regulatory support for the supplement industry.
- Determining the regulatory strategy required to bring the supplement to market in different jurisdictions;
- Conducting feasibility assessments to determine whether sufficient data exist to pursue successful applications in different jurisdictions;
- Providing recommendations to meet regulatory requirements for safety, efficacy, and quality;
- Providing product development support;
- Assisting in the design, placement, monitoring, and management of clinical trial protocols for health claim substantiation;
- Compiling technical and scientific submissions to regulatory authorities;
- Preparing expert opinion letters;
- Acting as a liaison with regulatory authorities during the submission review process; and
- Administering programs to meet post-market requirements, including adverse event reporting, regulatory monitoring, and surveillance programs.
- United States
- Dietary Supplements, New Dietary Ingredient (NDI) Notifications
- GRAS determinations
- Natural Health Products (NHPs)
- European Union
- Food Supplements (Novel Foods)
- Australia/New Zealand
- Complementary Medicines
- Supplement ingredients (FOSHU, FNFC, FFC)
- Health Food, nutritional supplements
- South Korea
- Health Functional Foods (HFFs)
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