For over fifeteen years, ARE Labs Inc. has been at the forefront of providing cGLP Regulatory Compliance Testing services, specializing in drug delivery devices. Our extensive experience in Nebulizer, Dry Powder Inhalers (DPI), Metered Dose Inhaler (MDI), Spacers, Intranasal sprays, Ventilators, and other aerosol delivery mechanisms and testing and a comprehensive suite of regulatory compliance testing services set us apart in the industry. We expertly navigate the complexities of FDA 510(k) compliance testing for a variety of devices, including nebulizers, MDIs, spacers, and intranasal delivery devices.
Comprehensive FDA 510(k) Compliance Testing: Our team is adept at conducting FDA nebulizer 510k compliance testing, FDA MDI 510(k) compliance testing, FDA spacer 510k compliance testing, and FDA 510k intranasal delivery device testing, ensuring your products meet all regulatory standards.
Unique and Advanced Testing Methodologies: Our proprietary setup combines the standard cascade impactor method with real-time in-situ particle size analysis. This innovative approach not only provides cumulative data but also time-sensitive insights like changes in particle size distribution, MMAD, and GSD throughout the treatment.
Professional Reporting: We provide fully documented, professional two-column journal article reports for each study, enhancing the confidence and visibility of your product in a way no other lab offers.
Critical for Clinical In-Vitro Characterization: The clinical in-vitro characterization of your aerosol drug device is vital for regulatory approval. Our detailed testing and analysis offer invaluable insights, aiding in the successful approval of your product.
Simulated Breathing Human Model: Our additional testing services include a simulated breathing human model, ideal for evaluating the total inhaled drug and real-time particle size data. With controlled variables like tidal volume, breathing frequency, and I:E ratios, we gather comprehensive delivered dose data under various respiratory conditions.
A Range of Drug Delivery Devices: Whether you need testing for nebulizers, MDIs, spacers, aerosol delivery masks, or combination devices such as ventilators, ARE Labs Inc. is equipped to handle all your cGLP regulatory compliance testing needs.
Customized Testing Solutions: We understand that each product is unique. Our team offers customized testing solutions to meet the specific requirements of your device and regulatory objectives.