- Business development
- Works with inventors, investors, start-up companies, and established commercial and institutional entities who wish to optimize value from the technologies they own through licensing, sale, commercial partnership, etc.
- Assists in identifying viable target markets, development resource, and potential commercial partners.
- Develops strategies to help clients reduce regulatory risk, thereby enhancing return on investment, through our understanding of the FDA approval process
- Product development
- Regulatory research, planning, and issue response
- Regulatory agency liaison
- Overall development planning
- Formulation development
- Pre-clinical development
- Bench testing (devices)
- In vitro testing
- General pharmacology
- Toxicology
- Pharmacokinetics/ADME
- Clinical development
- Clinical study design
- Clinical trial planning, including protocol development
- Study site monitoring and CRF review
- Site and project management
- Data summary and presentation
- Product submissions (initial and lifecycle)
- Human drug commercialization
- Product development/investigational drugs: Investigational New Drug Exemption Application (IND)
- Product approval:
- New Molecular Entity (NME): New Drug Application (NDA)
- Generic Drug: Abbreviated New Drug Application (ANDA)
- Biologics: Biologics License Application (BLA)
- Animal drug commercialization
- Product development/investigational drugs: Investigational New Animal Drug Exemption Application (INAD)
- Product approval: New Animal Drug Application (NADA)
- Medical device commercialization
- Product development/investigational devices: Investigation Device Exemption Application (IDE)
- Product approval or clearance
- Device approval: Premarket Approval Application (PMA)
- Device clearance: Premarket Notification (510(k))
- Humanitarian Device Exemption Application (HDE)
- European Conformity Assessment (CE Marking)
