FDA Testing: Whether it's FDA 510(k) compliance testing for nebulizers, MDIs, spacers, aerosol delivery masks, or complex devices like ventilators, ARE Labs Inc. is equipped to handle all your cGLP regulatory compliance testing needs.
DEA Testing: ARE Labs has schedule 1 clearance from the DEA allowing testing on schedule 1 substances such as marijuana. ARE Labs can assist with your DEA schedule 1 testing.
Unique Proprietary Testing Methods: Our exclusive setup integrates the standard cascade impactor method with real-time in-situ particle size analysis. This innovative approach delivers not only cumulative data but also critical time-sensitive insights, including changes in particle size distribution, MMAD, and GSD, enhancing the understanding of treatment dynamics.
Professional Reporting: Distinguishing our services, we provide fully documented professional two-column journal article reports for all studies, a unique offering designed to elevate the confidence and market visibility of your products.
In-Depth Particle Size and Treatment Analysis: Beyond standard data, our system offers valuable information on particle behavior and aerosol dynamics throughout the treatment, a feature unmatched by other methodologies.
Essential for Clinical In-Vitro Characterization: Understanding the necessity of detailed in-vitro characterization for regulatory approval, ARE Labs offers specialized testing and analysis crucial for navigating the FDA approval process.
Simulated Breathing Human Model Testing: Our advanced testing services include a simulated breathing human model, enabling us to evaluate total inhaled drug and real-time particle size data concurrently. We meticulously adjust tidal volume, breathing frequency, and I:E ratios to simulate various respiratory conditions, providing comprehensive data on delivered doses.