- Expert Testimony/Patent Infringement
- Manufacturing Route Selection
- Potent Compounds
- Process Validation
- Supply Chain/CMO Management
- Work Orders/MSAs/Terms and Conditions
- Small Molecules
- Antibody Drug Conjugates/Oncology and all types of Drug Development
- Project Management
- Quality Assurance/Manufacturing Batch Records
- Due Diligence CMC Review Support
- Regulatory Compliance
- Clinical Trial Support Strategies
- Formulation Development
- Analytical Controls
- Genotoxic Impurity Control
- FDA Type C Meeting Support/Pre-meeting Packages
- IND, NDA, BLA, DMF Content