Pre-clinical drug development

  • Pharmacology
  • Safety pharmacology studies
  • Toxicokinetics and toxicodynamics
  • Analytical and bioanalytical method development and analysis
  • Review and interpret complex pre-clinical data
  • Protocol Development/Study Monitoring/GLP Audit
  • Document generation, including writing SOPs, analytical methods, assay
    validation and bioanalytical reports, documents for regulatory submissions, and manuscripts

Research and Drug Discovery

  • Chemistry, manufacture and control (CMC) development
  • Quality Control management
  • Clinical Research Development
  • Regulatory strategies
  • Quality Assurance

Drug Research and Discovery Services

  • Assay development
  • High-throughput screening
  • Lead optimization chemistry
  • Retrieval and analysis of relevant literature
  • In vitro ADME and pharmacokinetic studies
  • Safety pharmacology studies
  • Toxicokinetics and Toxicodynamics

Drug Development Services

  • Pre-formulation
  • Formulation development strategy for both API and formulated drug product
  • Analytical Method Development
  • Analytical Method Validation
  • Raw material selection and GMP drug product manufacture and technology transfer
  • Packaging, labeling and distribution
  • Process Development
  • Stability
  • Microbiology

Drug Manufacturing

  • Semi-solids and Liquids
  • Steriles

Regulatory Services

  • Preparation of pharmacology, pharmacokinetic and toxicology sections for regulatory submissions
  • Review and consultation on non-clinical and regulatory issues affecting submissions
  • Preparation of CMC sections for regulatory submissions
  • Preparation of amendments, supplements and annual reports for regulatory submissions