In-vitro Bioequivalence (IVBE)

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.

Thanks to our lab test capabilities, we can support specific generic projects through a complete set of tests that meets the authority’s prerequisite. This data generation will be statistically analyzed regarding USA and EU guidelines for eventual customers’ IVBE dossier registration filing.