ARE Labs Inc. has been helping clients with cGLP Regulatory Compliance Testing for drug delivery devices for over 7 years. We have extensive experience with Meter Dose Inhaler testing and the corresponding Regulatory Compliance Testing following: FDA nebulizer 510k compliance testing, FDA MDI 510(k) compliance testing, FDA spacer 510k compliance testing and FDA 510k intranasal delivery device testing. Additionally, we can perform regulatory compliance testing. All of our studies come with a fully documented professional 2-coulmn journal article report suitable for publication to help increase the confidence and visibility of your product, no other lab offers this type of service.
We have a unique proprietary setup which combines standard cascade impactor method with real-time in-situ particle size analysis. This system will not only give you cumulative data that a cascade impactor provides but also time-sensitive data such as changes in particle size distribution, MMAD (Mass Median Aerodynamic Diameter) , GSD (Geometric Standard Deviation) over the duration of the treatment time. This added data can provide useful insight into your product that no other test methodology can provide. Clinical in-vitro characterization of your aerosol drug device is critical for regulatory approval of your product and ARE Labs can help you navigate and provide all your testing needs.
Additional testing services include a simulated breathing human model to evaluate total inhaled drug and real-time particle size data simultaneously. We can control tidal volume, breathing frequency and I:E ratios to gather delivered dose data under any respiratory condition.
Whatever your cGLP regulatory compliance testing needs are ARE Labs Inc. can help out. Let us take the mystery out of FDA 510(k) compliance testing for nebulizers, meter dose inhalers (MDI’s), spacers , aerosol delivery masks and even combination devices such a ventilators.
Typical Regulatory 510(K) Testing Project Timeline
Regulatory Compliance Testing
FDA 510(k) Testing
Nebulizer 510(k) Testing
Metered Dose Inhaler 510(k) Testing
Spacer 510(k) Testing
USP <601> Testing
Accelerated Aging Studies
Simulated Lifetime Testing
Respirable Dose and Fraction
Dose Uniformity Testing
Treatment Time Testing
Additional Benefits for Regulatory Testing with ARE Labs
With our extensive knowledge base and our multiple real-time laser diffraction particle size analyzers we can screen may different predicates to help select the best predicate which matches your medical aerosol device. This selection process helps to keep your cost down and helps to grantee a successful application process.
If you would like more information on nebulizer testing, MDI testing or Spacer Testing please visit our Aerosol Device Testing page.
nano-HPLC with UV detection (standard)
HPLC w CAD detection (API’s without strong UV signatures)
fluticasone / salmeterol
mometasone / formoterol