Software and computer modeling services for OINDP development, device design, and analysis. Inhaler testing software, CFD, airway modeling, nasal modeling, device modeling
Copley Scientific offers a fully validated, standalone, software package for analysis of inhaler testing data. Copley Inhaler Testing Data Analysis Software (CITDAS™) can be used with any pharmacopeia specified multi-stage cascade impactor and since its introduction, in 2000, has become an industry standard for the analysis and reporting of aerodynamic particle size distribution data for inhalers and nebulizers. Regularly updated to meet industry and regulatory requirements, CITDAS streamlines workflow, reduces the risk of calculation error, and enables consistent data reporting according to regulatory and pharmacopeia requirements. Direct importation of data from HPLC systems is also possible in some cases.
Emmace Consulting offers excellence in performance testing and advising in development of Orally Inhaled and Nasal Drug Products on a CRO-basis. Our strengths are in the following arenas: • Traditional testing of inhalers (DPI, pMDI, and nebulizers) including cascade impaction, laser diffraction, and delivered dose uniformity characterization according to US and EU Pharmacopeias • Experimental determination of expected lung dose from inhalers by using anatomically realistic mouth-throat inlets in combination with patient-like inhalation profiles (best-in-class in-vitro/in-vivo comparisons) • Strategic advising in CMC and clinical support and in lung dose modeling • Software for the prediction of particle delivery to the lung — Mimetikos Preludium™
VIOTA SOFTWARE EASES COMPLIANCE BURDEN
Viota® software manages every aspect of Proveris Scientific’s instrumentation. All critical parameters including methods, samples, and operator identification are recorded for complete traceability. The software’s client-server architecture ensures that data is collected and stored securely, and available for instant recall. The easy-to-view user interface makes it simple for operators to examine collected high-quality data with all the exporting and visualization tools needed. Data can be used to quickly identify and assign root cause for OOS investigations. Controls and a complete Audit Trail enables regulatory compliance for electronic records, electronic signatures, audit trails, and data/system/user traceability.
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