Early and full drug development is regulatory-driven and complex. The priority in this selection process is to achieve the safety and efficacy of a new molecular entity. The preclinical activity includes mainly safety and pharmacological testing accompanied by metabolism, bioanalysis, biomarker development and pharmaceutical analysis. 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.
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. 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.