Let us provide a critical piece to your product development.
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.
- 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...
- Rare diseases
- Infectious disease
- Next Generation Sequencing (NGC)
- cell-free DNA (cfDNA)
- Flow Cytometry
- Immunohistochemistry (IHC)
- Digital image analysis
- To name a few...
Ready to find out more?
Contact us today with questions or to discus your project.