A3Z Advanced

A3Z advanced provides quality control/quality assurance/regulatory affairs services to pharmaceutical, cosmetics, nutraceutical, and medical device manufacturers. Our areas of activity are: 1. QUALITY SYSTEM ASSURANCE: For us, the regulatory compliance of our customers is a core question. A3Z advanced has developed a dynamic procedure to assess the quality system of our customers is fitted to its purpose and functional. We also can in-situ work to accelerate GxP, UNE-EN ISO 22716, ISO 13485 and ISO 9001 quality management systems implementation. 2. REGULATORY AFFAIRS: A3Z advanced provides consultancy and insoruced services to medical devices/in-vitro medical deviced covering: - Market Access - Registrations in/outside Europe - Technical file for CE marking (MDR 2017/745 and IVDR 2017/746) - Manufacturer, importer and distributor licence - Post Market Surveillance - Clinical evaluation - ISO 13485:2016 Quality Management System. We have strong expertise in: - CE technical file management for standalone-software and other machine learning-based medical devices marketing autorization. -MDR-update of technical files of MDD devices is in our scope. 3. ANALYTICAL METHODOLOGY DEVELOPMENT and validation of proprietary and non-proprietary analytical methods for excipients, APIs, intermediate products and finished products, small molecules in biological samples, and active ingredients from botanical sources according to the ICH Q2 and USP guidelines. Simplicity and robustness are the two main properties of our analytical developments. An advanced procedure for method transfer to sponsor facilities is the third feature that defines our work. Our partnership philosophy includes a continuous support to the customer beyond the method transfer to the client’s laboratory.