Nemera
In-vitro Bioequivalence (IVBE) for Nasal Sprays
FromNemera
Off-the-shelf devices available for key identified nasal drugs. Accelerate your sprint to market with our Device Equivalence Program. Based on FDA requirements, we have established a Device Equivalence Program in order to accelerate time-to-market and achieve in-vitro bioequivalence requirements. Our main objective is to preselect and propose an appropriate delivery system per identified drug to companies wishing to save time in their nasal spray development programs.
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- Off-the-shelf devices with IVBE requirements on priming/ re-priming, dose delivery and spray characteristics
- Several pump/ actuator combinations developed
- Various neck finishes: screw-on, snap-on and crimp-on
- “Fast-track” program meeting FDA IVBE requirements
- Based on track-record SP270+ platform and customized actuators
- In vitro Bioequivalence testing with state-of-the-art lab equipment, from screening tests to registration purposes
- Dedicated program & teams to answer a comprehensive clients’ support, including regulatory and statistic
A unique approach to achieve bioequivalence requirements
Our Device Equivalence Program will give you a high confidence level on results of the final product registration thanks to this preliminary bioequivalence study.
Its objective is to propose a delivery system with comparable performance to the branded device in terms of design, patient usage and performance characteristics.
Our Device Equivalence Program is 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 can perform in-vitro bioequivalence study and tests with your formulations in our laboratory and support your registration process:
- In-vitro bioequivalence testing
- Different statistical calculations depending on regional needs
We also have developed off-the-shelf bioequivalent devices for some key nasal drug products.