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Destination Pharma
CSV Life Science is the original and historic branch of the Group that, for 25 years, has been providing engineering and validation services for the Life Science sector (chemical-pharmaceutical, API, Biotechnologies, Nutraceuticals, Medical Devices).
It is among the leading companies in Italy providing engineering solutions and implementations for plants and services supporting business processes directly related to production.
The expertise developed by CSV Life Science ensures that businesses receive the most effective solutions to their challenges.
CSV Life Science
CSV Life Science is capable of offering integrated solutions by fully traversing the Life Cycle of a product or process. Starting from the preliminary feasibility study phase, often strategic, for new or existing production sites, it then develops the Conceptual Design, Basic Design, and Detailed Engineering. This extends to support during the purchasing phase and follow-up.
CSV Life Science stands by the client until the very last stages of a project, also offering Commissioning and Qualification services, and support in the two typical functions of a pharmaceutical company, namely Quality Assurance and Quality Control.
The extensive experience of CSV Life Science in the pharmaceutical industry and the solid understanding of GMP/FDA allows offering companies support in strategic decisions for a better and more informed definition of process needs.
These activities aim to identify the technical and economic feasibility of the project to define the path of subsequent engineering phases.
It starts with the definition of strategic concepts to optimize production processes in relation to flows (materials, people, and means) and culminates in defining the optimal plant, technological, and procedural solutions, compatible with the given constraints.
A specific characteristic of this area involves the study and design of movement and storage systems (Material Handling) to support the aforementioned processes.
With 25 years of expertise in the harmaceutical sector and the technical background of the chemical engineers that make up the robust engineering section, we are equipped to handle the design of processes and the initiation of pharmaceutical plants.This encompasses both the secondary production domain related to finished and packaged products, as well as the design of plants and/or production sites for active ingredients (API) where the process and its engineering require specific technical skills coupled with a GXP sensitivity.
CSV Life Science supports clients in all quality-related activities, such as plant validation and verification, QA and QC support, and consultation on GMP issues..
Commissioning activities document the correct installation, proper functioning, and compliance with specific requirements of equipment, plants, environments, such as cleanrooms, and utilities. These activities then serve validation by providing documented evidence with a high degree of assurance that a specific process consistently produces a product in line with predefined specifications.
Our validation services, in constant collaboration with the appointed figures within the manufacturing companies, are thus aimed at ensuring full compliance with all necessary GMP requirements.
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