Therapeutic Device Development

FDA recognizes combination products as therapeutic or diagnostic products where the mechanism of action is based on a combination of drugs, devices, and/or biologics. Advancements through the development of combination products are important and challenging, offering the potential to bring new and exciting treatment options to patients.

We have extensive knowledge of and experience in product design, pre-clinical testing, clinical evaluations, and regulatory submissions for companies working to get their combination medical products developed and approved for commercialization.

Therapeutic Device Development Services

• Medical Device Development
  • Concept development
    • Rapid prototyping and formative throughput testing
    • Summative testing – the “killer experiment”
    • Alignment with fund raising activities
  • Formal design and development of devices
    • DHF, RMF
• Analytical Testing
  • Analytical Services
  • Analytical testing
  • Analytical method development
  • Residual solvent testing
  • Drug release, elution studies
  • Dose uniformity studies
  • Drug-coated device testing
  • Drug or biologic + device testing
• Medical Device Testing
  • Stability testing and storage per ICH conditions
  • Human factors and usability studies