Regulatory
- Regulatory strategy for device clearance or approval
- Communication with FDA
Writing and editing of FDA submissions:
- Q-Submissions
- 510(k)
- De Novo
- PMA
- IDE
- HDE
- CLIA
- 513(g)
- PMA supplements
- Emergency Use Authorizations
- Companion Diagnostics
Scientific
- Analytical and clinical study design to meet FDA requirements
- Processing and statistical analysis of analytical and clinical data
- Facilitating the transition from research and development to FDA clearance or approval
Areas of Expertise
Clinical Indications
- Neurology – Traumatic Brain Injury and Alzheimer’s Disease
- Oncology tumor markers and genetics
- Autoimmune
- Allergy
- Immunology
Technologies
- Mass Spectrometry
- Flow Cytometry
- Immunoassays
- Molecular/NGS
