Services
Preclinical Knowledge Base
- Full IND packages – small/large molecule, immune-oncolytics
- Exploratory tox studies – including small/large animal imaging
- Regulatory toxicity studies – 2 week to 2 year
- Genotoxicity studies
- Reproductive toxicity studies
- Carcinogenicity studies
- Safety Pharmacology Studies
- Toxicokinetic Studies
- Drug-metabolite studies
- Drug-impurity studies
- Inhalation Toxicity studies
Clinical Knowledge Base
- Phase I-IV
- Regulatory Monitoring
- Medical Writing
- Quality Assurance
- Data Management
Bio-analytical / Analytical Knowledge Base
- Biosimilars
- Small/Large Molecules
- Immunogenicity Assays \ Immune Functional End Points
- Method Development & Validation
- LCMS/HPLC/ELISA/FACS
Regulatory Knowledge Base
- IND
- NDA
- 510 (k)
- 505 (b)(2)
Scientific Consulting
- Study Monitoring
- IND Enabling Designs
- NDA Enabling Designs
- Preclinical Program Management
Customized Solutions
- Formulation Development
- Discovery Models
- Translational Research
Drug Discovery Knowledge Base
- Metabolic Diseases – Diabetes, Obesity, Dyslipidemia etc
- Inflammatory Diseases
- Pain/Degenerative Diseases
- Infectious diseases
- Neglected Diseases
- Immune disorders
- Vaccine development
- Oncology/Anticancer
- Cardiovascular
- Neuroscience
- Non-Alcoholic SteatoHepatitis (NASH)
- Large Animal Imaging Studies
- Infusion Studies
Financial Services & Corporate
- Business planning / financial projection
- Corporate re-structure
- Interim management
- Forensic financial analysis