Let us provide a critical piece to your product development.
![shutterstock_565199140 shutterstock_565199140](https://elevationsd.com/wp-content/uploads/2019/02/shutterstock_565199140-1-300x200.jpg)
Our specialization is in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion (FDA, EMA, & ROW).
We offer tailored regulatory affairs consulting from large perspective planning to detailed implementation.
All regulatory affairs consulting and services can be combined with medical writing activities.
Expertise in:
- In vitro diagnostics (IVDs)
- Laboratory Developed Tests (LDTs)
- Therapeutic/CDx Codevelopment
- Biomarker hypothesis development
- Assay validation
- Software as a Medical Device (SaMD)
- Pharmacodynamic endpoints
- And more...
Therapeutic areas:
- Oncology
- Immuno-oncology
- Rare diseases
- Inflammation
- Infectious disease
Methodology Expertise:
- Next Generation Sequencing (NGC)
- cell-free DNA (cfDNA)
- Flow Cytometry
- miRNA
- Immunohistochemistry (IHC)
- Digital image analysis
- To name a few...
Ready to find out more?
Contact us today with questions or to discus your project.