ENGINEERING AND GMP SERVICES

Our historical branch, CSV Life Science, has been providing engineering and validation services for the Life Science sector (Chemical-Pharmaceutical, API, Biotechnology, Nutraceutical, and Medical Devices) for 25 years. We are among the first companies in Italy to provide engineering solutions and implementations for plants and services supporting business processes directly related to production. We offer integrated solutions running entirely through the life cycle of a product or process. Starting from the preliminary phase of the feasibility study, often strategic, for new or existing production sites, we then develop conceptual, basic, and detailed engineering design, all the way through to the support phase of procurement and follow-up. We stay with the client until the final stages of the project, offering Commissioning and Qualification services. Services offered: • Facility Planning: strategic decision support for better and more informed definition of process requirements, identification of technical and economic feasibility of the project to define the path of subsequent engineering phases. • Engineering: process design and pharmaceutical plant start-up, both in secondary production of finished and packaged products, and for active ingredient manufacturing (API) plants and/or sites where the process and engineering of the same require specific technical skills while having GXP sensitivity. • Commissioning, Qualification & CSV: We support clients in all quality-related activities, such as plant validation and validation, QA and QC support, and consulting on GMP issues. We also offer Computer System Validation and quality assurance services.