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