CRO/Research Consulting
Preclinical Research
AIBMR Life Sciences can assist your company in substantiating the safety
of your ingredients and products by coordinating studies in the areas of:
- Acute, subchronic and chronic toxicity studies
- Pharmacokinetics
- Pharmacodynamics
- Genotoxicity
- Neurotoxicity
- Reproductive toxicity
- Immunotoxicity
Public perception is that natural products are largely free from toxicity.
However, some natural products have caused adverse events. Ultimately, liability
rests on the shoulders of the company that sells the product. Therefore companies
manufacturing or distributing dietary supplements need to understand the
importance of substantiating the safety of their products. Companies should
be able and prepared to:
- Substantiate the safety of the ingredient or product in question.
- Have available toxicological studies that your company has commissioned
or conducted that demonstrate the ingredient or product is safe when used
as directed. the ingredient or product meets current Good Manufacturing
Practices (cGMPs), including substantiation of the product’s potency,
purity, and stability.
AIBMR Life Sciences can help your company conduct research
investigating the safety of your products. We believe strongly that this
is both a sound and wise investment for all natural products companies. All
AIBMR Life Sciences studies are conducted in strict adherence to Good Laboratory
Practice (GLP) standards and in accordance with accepted protocols.
The FDA’s Role in Safety
FDA has the statutory authority under the Dietary Supplement Health and
Education Act of 1994 (DSHEA) and other Acts passed by Congress to:
- Refer for criminal action any company that sells a dietary supplement that
is toxic or unsanitary.
- Seize dietary supplements that pose an “unreasonable or significant
risk of illness or injury.”
- Stop a new dietary ingredient from being marketed if the FDA has questions
regarding its safety from the pre-market notification it receives.
- Stop the sale of an entire class of dietary supplements if the agency
feels they pose an imminent public health hazard.
