Nonclinical Sciences
NGT BioPharma Consultants understands the scientific and regulatory challenges companies face evaluating Late Discovery drug candidates and advancing them through nonclinical and clinic development. We work collaboratively with our clients to efficiently support and integrate the multidisciplinary evaluations required to characterize key drug properties, including pharmacology, safety toxicology, pharmacokinetics, and CMC attributes enabling 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 to support a drug candidate’s proposed clinical indication and clinical development plan.
To address the scientific complexities of 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.
- Devise nonclinical strategies that support clinical development plans and proposed indication
- Exploratory and investigative toxicology
- PK/PD evaluation, preliminary human dose/exposure projections and safety margins
- Non-clinical and regulatory strategies and study oversight
- Nonclinical pharmacology and translational assessment
- Pharmacokinetic and metabolism profiling
- IND-enabling toxicology studies – interpretation and integration, including pathology, PK/PD, etc. along with long-term and specialty toxicology evaluations
- Provide PK/PD modeling support and evaluate predictive models
- Coordinate and oversee outsourcing of nonclinical studies
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.
