Respiratory Device Testing
Respiratory Device Testing
At ARE Labs, we excel in providing specialized testing services for pharmaceutical aerosol devices, ensuring precision and compliance in drug delivery technologies. Our comprehensive testing capabilities include:
Comprehensive Testing for Respiratory Devices
Comprehensive testing services such as particle size analysis, spray pattern and plume geometry.
ARE Labs has experience a wide range of devices such as meter dose inhalers, nasal delivery devices, dry powder inhalers and nebulizers.
Delivered Dose Analysis for Respiratory Devices
Utilizing next generation cascade impactors along with HPLC analysis we can help determine effective delivered dose for respiratory devices.
Pharmaceutical Regulatory Testing
Navigating the complex landscape of regulatory compliance is crucial for pharmaceutical success. ARE Labs is adept at providing essential testing and documentation support for:
FDA and DEA Submissions:
Comprehensive testing services tailored to meet FDA and DEA regulatory requirements.
Assistance with submission processes to ensure compliance and approval.
International Regulatory Bodies:
Expertise in conforming to global pharmaceutical standards and regulations.
Support for navigating international regulatory frameworks and submissions.
Pharmaceutical Formulation Services
Pharmaceutical Formulation Services
At ARE Labs, we are dedicated to advancing respiratory healthcare through our expert drug formulation processing services. Our specialization lies in creating and optimizing drug formulations for aerosol inhalation delivery, encompassing a range of forms such as dry powder, aqueous suspensions, and solutions.
Aerosol Inhalation Formulations:
ARE Labs has extensive experience enhancing and creating respiratory drug formulations for a variety of medical devices.
In addition ARE Labs can determine delivered dose data through cascade impactor testing ensuring the efficacy of your new formulation.
Pharmaceutical Packaging Testing
Ensuring the longevity and safety of pharmaceutical products is paramount. ARE Labs offers specialized testing services to guarantee product integrity throughout its lifecycle:
Packaging Integrity Testing:
Evaluations to ensure pharmaceutical packaging maintains product sterility and protection.
Tests for seal strength, material compatibility, and barrier properties.
Storage Stability Testing:
Stability assessments under various environmental conditions to determine shelf-life.
Analysis of pharmaceutical efficacy and safety over time.