In-vitro nasal bioequivalence
Off-the-shelf devices avaible for key identified nasal drugs
Nemera can perform screening testing with customer formulations and support your registration process
TEST | REQUIRED BY THE FDA |
|---|---|
Dose Delivery | ☑ |
Droplet Size Distribution | ☑ |
Spray Pattern | ☑ |
Plume Geometry | ☑ |
Priming / Repriming | ☑ |
Development based on FDA requirements:
- Specific program to meet requirements for in-vitro bioequivalence
- customized testing methodologies with state-of-the-art lab equipment
- Advanced statistical analysis
We have developed off-the-shelf bioequivalent devices for some key nasal drug products.
Able to offer expertise in market understanding, regulatory affairs, device development and statistical analysis, we are cooperative, committed and responsive device design partner.
Please consult for any question.
Nemera has established a Device Equivalence Program in order to accelerate time-to-market and achieve bioequivalence requirements.
