Preclinical

SERVICES - PRECLINICAL AND NONCLINICAL DRUG DEVELOPMENT

Preclinical and nonclinical drug development is a critical component of drug development and making poor or misinformed decisions can significantly delay or kill a drug, and waste valuable resources and investments.

The goal of preclinical and nonclinical research must be strategically designed and aligned to support a drug approval. In addition, vital issues need to be considered early, such as the timing of “must have” and “nice to have” studies, as well as issues ranging from which animal species would be most appropriate, to which facility can validate the bioanalytical assay or scale up and supply GMP API.

CSSi LifeSciences™ provides strategic guidance, planning and execution to save you time and costs.

Working with a medical device

PRECLINICAL AND NONCLINICAL DRUG DEVELOPMENT STRATEGIC GUIDANCE AND CONSULTING SERVICES INCLUDE:

  • Compound assessment and selection
  • Go/no-go analysis
  • Analytical methods transfer/development and validation
  • Characterization
  • Process development and scale up
  • Production of toxicology batch and reference standard
  • Production of a Good Manufacturing Practices (GMP) clinical batch and reference standard
  • Release testing
  • Storage stability
  • Labeling and Packaging
  • Therapeutic indexing
  • Sourcing of proof-of-concept animal models
  • Guidance on appropriate animal species for safety testing
  • Development and validation of bioanalytical methods
  • Formulation analysis
  • Animal PK/PD studies
  • General animal toxicology (GLP)
  • Safety pharmacology
  • Drug interaction
  • Immunogenicity
  • Metabolism and distribution
  • Carcinogenesis, mutagenesis and fertility
  • Methods Development / Method Qualification
  • Preformulation Studies
  • Formulation Development
  • Stability Studies