When developing a device-drug combination, it is important to optimize the delivery approach early on in the process. We are here to help you throughout the entire process of developing your biological drug and medical device so that a comprehensive plan can be developed for your product. Our main focus is to assist in getting your product through 510(k) clearance or PMA approval.
- Extractables & Leachables Testing
- Drug-device Compatibility Studies
- Drug-eluting Studies
- Analytical Method Development & Optimization
- Material Characterization
- Impurities Testing & Forced Degradation Studies
- Customized Analytical Development
At VxP Biologics, we recognize the potential for components to negatively impact your drug-device combinations, and can strategically develop a rigorous compatibility protocol for effectively testing your packaging components.