FDA Expertise:

• Clinical development planning
• Medical literature review
• Editing of FDA Medical Device Presubmissions
• Investigational New Drug submissions
• Investigational Device Exemption or Humanitarian Device Exemption submissions
• Guidance in navigating FDA premarket reviews

Patent Expertise:

• Patent search using EAST engine of the of the US Patent Office

Engineering Expertise:

• Real-time electronic signal acquisition
• Data filtering, processing and analysis
• Simulation modeling: chemical process control, separations, mechanical, or electrical systems
• Mechanical prototyping by additive manufacturing in fused deposition plastic or computer numerical controlled soft metal machining
• Electroplating in precious metals
• Optical scanning and reverse engineering from point cloud to parametric models