We provide comprehensive analytical services for product development in combination with nebulizer optimization from early phase to submission and commercialization.
Experienced scientists design in-vitro aerosol studies according to industry guidance. Together with well-trained staff, they perform studies using state-of-the-art instrumentation and methodologies of the highest analytical quality. This makes it possible to provide our customers with detailed reports for regulatory submission.
With decades of experience in aerosol testing, we provide a broad range of analytical support for non-clinical, pre-clinical, and clinical phases of pharmaceutical product development.
Aerosol characterization of drugs and devices is performed in multiple, specially designed, temperature and humidity controlled lab spaces. These laboratories are fully accredited to the highest quality standards (GMP and ISO 13485).
We offer customized analytical solutions based on the particular projects' requirements. Methodology is adapted in each case with industry guidelines, pharmacopeias (e.g. Ph. Eur., USP, BP, JP) and customer specifications.
Methods developed and available for different molecules and formulations:
Analytical methods for the determination of:
Our expertise also extends to analytics of pressurized metered dose inhalation products (pMDI), along with VHCs with facemasks and dry powder inhalation products (DPI).
Thanks to various models, we are able to simulate various scenarios with different devices and products.
Our aerosol laboratory is equipped with fully qualified state-of-the-art instrumentation. A wide range of HPLC detectors allows the analysis of a great variety of molecules and formulations. Traditional HPLC methods can be transferred to faster UPLC methods.