NGT BioPharma Consultants understand the scientific and regulatory challenges companies face when evaluating drug candidates from final compound selection to advancing those drug candidates through nonclinical and clinic development. NGT will work collaboratively with our clients to create regulatory strategies that efficiently integrate the multidisciplinary evaluations required to characterize key drug properties, including pharmacology, safety, pharmacokinetic, and CMC characteristics that allow progression into the clinic and ultimate market approval. We understand these critical interdependencies and will leverage our collective expertise and extensive experience to develop nonclinical plans that will support a drug candidate’s proposed clinical indication and clinical development plan.
Preclinical and Early-Stage Development
To address the scientific and regulatory complexities of early drug development, NGT brings a robust team of highly experienced subject experts to counsel and often lead the strategies and experimental approaches of advancing a drug candidate through preclinical and early clinical evaluations. The core scientific and technology foundations supporting early development include:
Clients often engage NGT teams in a variety of ways to meet their business and scientific needs. Drawing on NGT’s scientific leadership, we have supported many of the following activities:
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO ’s.