PROPOSAL - Company Profile CSV

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CSV Life Science pure engineering, pure passion


ONE Our approach: clear, concrete, evident. A journey always begins with the first step.

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CSV Life Science serves the pharmaceutical market with engineering solutions and validation services for the Life Science sector, offering significant GxP expertise. Our track record includes leading-edge solutions for the Secondary Pharmaceutical Industry, Medical Device Manufacturers, Laboratories and API Companies, as well as the Fine Chemicals and Food Industries. CSV Life Science has the experience and specialist resources to provide an integrated service covering the entire product life cycle, from the conceptual design and analysis of a department or whole manufacturing site through to basic and detail engineering, qualification, validation and the resolution of any related product release problems in accordance with all the relevant standards. CSV performs in the fields of Validation and Engineering. Over the years, CSV Life Science, has built on the leading expertise of the engineering professionals that founded and drive the company to provide leading-edge Validation, Compliance and Computer System Validation services that are closely tailored to the needs of our customers, both large and small alike. Our know-how in the pharmaceutical and chemical industries brings our clients total peace of mind, knowing that they can rally on a complete solution that addresses every related issue for their company, with a synergistic integration of validation and engineering experience and expertise. It has likewise gained us recognition for delivering the benefits of validation services that are principally orientated to resolving rather than simply identifying any nonconformities encountered. At the same time, we make us an ideal partner for companies seeking the highest standards of professionalism together with outstanding operating flexibility, a combination that can make all the difference to small and medium projects.

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Free to dream Able of achieving. CSV Life Science: high professional level and great flexibilty in process.

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FAISIBILTY STUDY&FACILITY PLANNING ENGINEERING DESIGN CONSTRUCTION CONTAINMENT VALIDATION COMPUTER SYSTEM VALIDATION

How do you know The only thing more important than the result is the method to obtain it. Our services meet all needs in a comprehensive and flexible way.

GMP SOLUTIONS

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CONSTRUCTION MANAGEMENT CSV Life Science serves the pharmaceutical market with engineering solutions and validation services for the Life Science sector, offering significant GxP expertise. Our track record includes leading-edge solutions for the Secondary Pharmaceutical Industry, Medical Device Manufacturers, Laboratories and API Companies, as well as the Fine Chemicals and Food Industries. CSV Life Science has the experience and specialist resources to provide an integrated service covering the entire product life cycle, from the conceptual design and analysis of a department or whole manufacturing site through to basic and detail engineering, qualification, validation and the resolution of any related product release problems in accordance

Construction Construction is an instinct. Our method is to do it perfectly.

with all the relevant standards.

CONSTRUCTION Lump sum turn key solutions CSV LIFE SCIENCE supports our customers in construction phase, supplying plants on Lump Sum Turn Key (LSTK) basis, and/or providing on site Project Management and Construction Supervision services. During construction phase, a Construction Manager is present at the job site for the whole period of construction and is responsible for coordination of all field activities.

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ILC DOVER CSV Life Science is actually the exclusive agent on the Italian market for the American company ILC Dover, which, whether protecting personnel in hostile environments, containing potent powder pharmaceuticals, or developing unique inflatable devices, have an enviable record of performance. Once again, by drawing from a blend of highly qualified personnel with ten-years experience, CSV Life Science continues to be active in the pharmaceutical market as a leading company, always looking for the most innovative solutions in the pharmaceutical field. So that for their tenth anniversary, CSV Life Science become the exclusive partner for a such highly qualified company as it is ILC Dover. CSV Life Science partners are international companies focused both on engineering technical solutions in the application of flexible containment, and in developing process installation for liquid and powder handling.

Containment We provide the best and most cost effective solutions available

So that with a multi-disciplined technical expertise, CSV Life Science can provide inventive solutions for a wide range of applications, supporting clients in approaching, developing and testing customized containment systems. Product and Services: provide the best and most cost effective solutions available. We also provide all services for the integration of these materials in existing installations. These companies offer ideal solutions for all problems of containment, whether for new installation or for updates. Product and Services DoverPac速 DoverPac Continuous Liner System DoverPac SF Drum Transfer System DTS Flexible Glove-Boxes Milling under protection Flexible clean room Aseptic / Steril flexible isolators Turn Key Containment Solution SMEPAC Test Powoder Flexible wnading System

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COMPLIANCE The Compliance team offers specialist quality assurance competencies that not only enable them to deliver an “internal quality guarantee service” for our engineering and validation projects, but also to provide our clients with expert support for the typical functions required of their own Quality Assurance and Quality Control organizations and systems. This service is in increasing demand as a result of the relentless pace of today’s technological innovations and constant amendments to the quality and safety requirements of regulatory bodies, which have inevitably led to increasingly rapid changes in the international standards applicable to the pharmaceutical sector. We respond to this need by ensuring that it always keeps pace with the times and is able to provide every client that needs to comply with these changes with a support service that delivers prompt and effective solutions. We offer our clients a full spectrum of services in this area, including:

GMP SOLUTIONS Everything in its place for perfect conclusion

Compliance area boast of competence in production systems and equipment

Process, cleaning and methods validation Validation Documentation Review Personnel training QA & QC SOP writing Internal and Supplier Audits GMP reviews Rules and guidelines (US & EU) consultancy Regulatory Issues

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Data Sheet Services&Case Histories


CSV LIFE SCIENCE Via Selvanesco 75 20142 MILANO Italia info@csv-ls.com www.csv-ls.com Phone 02 274393.1 Fax 02 274393200


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