Regulatory Compliance
More today than ever before, nutraceutical companies can’t be too cautious
in ensuring compliance with FDA, FTC and foreign regulations. Compliance issues
are complex, and gaining a comprehensive understanding of the laws and
regulations is often extremely challenging.
AIBMR Life Science’s team of experts can help support your regulatory
challenges with:
- FTC, FDA and DSHEA compliance
- SOP Development
- Labeling
- cGMP’s
- Claims Development and Substantiation
- Mandatory AER (Adverse Event Reporting) guidance
- Domestic and Foreign compliance issues
We can provide in-depth literature and research reviews to help assess
claim substantiation, and with our library and scientific database we can provide
substantiation for structure-function statements as required under DSHEA.
We also provide trade/consumer ad review for compliance with FTC advertising
and marketing regulations. If you like, we can even recommend and coordinate
research studies that could identify new claims or make your old ones stronger.
At AIBMR Life Sciences, we provide experience and know-how when assisting
in the development of new dietary supplement labels, helping you comply with
the FDA’s guidance on labeling. It is crucial to be informed of all required
components of dietary supplement packaging, and we can help you make sure your
packaging measures up.
Our Industry Connections
At AIBMR Life Sciences, our collaborative relationships with experts from governmental
and industry organizations are essential in helping to answer your tough
questions quickly and accurately. We offer day-to-day technical assistance
available by phone, email or teleconferencing. We take pride in making
ourselves available for timely and efficient assistance.