FDA Regulatory Testing
ARE Labs Inc. has been a leader in cGLP Regulatory Compliance Testing for drug delivery devices for over seven years, specializing in Metered Dose Inhaler (MDI) testing and other devices. Our expertise in FDA 510(k) compliance testing encompasses nebulizers, MDIs, spacers, and intranasal delivery devices, distinguishing us in the industry for our comprehensive regulatory testing services.
Comprehensive FDA 510(k) Compliance Testing: Our team is adept at conducting FDA 510(k) compliance testing for nebulizers, MDIs, spacers, and intranasal delivery devices. We ensure your products meet all of the 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.
DEA Schedule 1 Testing
DEA Schedule 1 Testing:
ARE Labs provides expert DEA Schedule 1 pharmaceutical testing services, specializing in the analysis of substances subject to the strictest regulatory oversight. Our state-of-the-art laboratory is equipped with cutting-edge technology and staffed by experienced professionals skilled in managing and analyzing Schedule 1 controlled substances. These include drugs with a high potential for abuse and no currently accepted medical use in the United States, ensuring rigorous and reliable testing results.
Purity and Potency Analysis: We provide detailed testing for the purity and potency of Schedule 1 substances, crucial for research and development purposes, and regulatory submissions.
Impurity and Contaminant Identification: Our analytical services extend to identifying impurities and contaminants, ensuring the integrity and safety of the substances under investigation.
Customized Analytical Solutions: We tailor our testing services to meet the unique needs of each project, whether it's for pharmaceutical research or legal compliance.
Navigate Regulatory Compliance with Confidence with ARE Labs Inc.
Partner with ARE Labs Inc. and demystify the complexities of FDA 510(k) compliance testing. Our expertise in cGLP regulatory compliance testing, combined with our innovative methodologies and detailed reporting, ensures your drug delivery devices are not only compliant but also set for market success. Contact us today to explore how we can support your testing needs and enhance your product's journey to regulatory approval.