Regulatory Compliance Consultation Services
More today than ever before, natural product companies that sell, market, or distribute in the USA need to be certain they meet the regulatory requirements of the FDA and FTC. Failure to do so can result in significant penalties. Compliance issues are complex, and gaining a comprehensive understanding of the laws and regulations is often extremely challenging. Let AIBMR’s expert regulatory compliance consultants assist you in this process.
AIBMR can help support your regulatory challenges in the following areas:
- FTC and FDA regulatory compliance consultation (including DSHEA)
- Label reviews (including product, website, and all marketing material)
- Claims development and substantiation
- Structure/Function claims
- Mandatory AER (Adverse Event Reporting) guidance
- California’s Proposition 65 compliance
- Supplementology®: We provide technical consultation in the field of research, development and formulation of nutraceutical, botanical and natural preparations.
We provide in-depth literature and research reviews to help assess claims support, as required under DSHEA. We also offer trade/consumer ad review for compliance with FTC advertising and marketing regulations. If desired, we can recommend and coordinate research studies that could identify new claims or make your old claims stronger.
AIBMR brings experience and know-how when assisting in the development of new dietary supplement labels, therefore helping you with FDA compliance. It is crucial to be informed of all required components of dietary supplement packaging, and we are here to ensure your packaging measures up.