Quality Comes First
BioSante recognizes that product quality is fundamental to consumer confidence. Our product-development and supply-chain approach incorporates quality considerations from ingredient selection through finished-product review.
Quality System Activities
Our product-development and supply-chain approach incorporates quality considerations from ingredient selection through finished-product review.
- Ingredient qualification
- Supplier evaluation
- Product specifications
- Manufacturing controls
- Batch documentation
- Quality testing
- Packaging controls
- Label review
- Finished-product review
Manufacturing & cGMP
Where applicable, BioSante’s manufacturing partners are expected to operate under the applicable FDA current good manufacturing practice requirements for dietary supplements.
Important Regulatory Distinction
Dietary supplements are regulated as a category of food under U.S. law. FDA generally does not pre-approve dietary supplement products, labels, or structure/function claims before marketing. Companies are responsible for ensuring that their products and labeling comply with applicable law.
Responsible Product Communication
BioSante’s website and product communications are intended to describe nutritional support, normal physiological functions, general wellness, and product characteristics. Disease diagnosis, treatment, cure, or prevention claims should not be used for a dietary supplement unless a legally applicable pathway specifically permits the claim.