Pre-clinical and non-clinical research are the stepping stones to subsequent clinical trials. This early research is valuable for confirming your product or ingredient’s mechanism of action, in vivo proof-of-concept, and safety profile including toxicology, carcinogenicity, genotoxicity, and teratology.
The level of pre-clinical research needed to substantiate a dietary supplement claim depends on the regulatory environment of the country you wish to sell in. Reviewing the pre-clinical program more strategically may be costlier initially, but this will save time and money later in development – especially in cases where the product will be marketed in multiple regions or categories.
At Nutrasource, we work with our clients to prepare comprehensive plans to minimize the time spent on pre-clinical programs in the context of overall program development while being cognizant of budget frameworks and restrictions. Our team can assist with strategy and oversight as well as reviewing protocols, site selection and management to place studies at GLP sites, and conducting bioanalytical testing to support product development.
Learn how we can help you manage your pre-clinical program to the highest level of quality.