CSV Life Sciencepure engineering, pure passion

ONE

A journey always begins with the first step.Our approach: light, real, ideal.

1 2

Free to dream

CSV Life Science: high professional level and great flexibilty in process.

Able of achieving.

3

CSV Life Science serves the pharmaceutical market withengineering solutions and validation services for theLife Science sector, offering significant GxP expertise.Our track record includes leading-edge solutions forthe Secondary Pharmaceutical Industry, Medical DeviceManufacturers, Laboratories and API Companies, aswell as the Fine Chemicals and Food Industries.CSV Life Science has the experience and specialistresources to provide an integrated service covering theentire product life cycle, from the conceptualdesign and analysis of a department or wholemanufacturing site through to basic and detailengineering, qualification, validation and the resolutionof any related product release problems in accordancewith all the relevant standards.CSV performs in the fields of Validation and Engineering.Over the years, CSV Life Science, has built on the leadingexpertise of the engineering professionals that foundedand drive the company to provide leading-edgeValidation, Compliance and Computer System Validationservices that are closely tailored to the needs of ourcustomers, both large and small alike.Our know-how in the pharmaceutical and chemicalindustries brings our clients total peace of mind, knowingthat they can rally on a complete solution that addressesevery related issue for their company, with a synergisticintegration of validation and engineering experienceand expertise. It has likewise gained us recognition fordelivering the benefits of validation services that areprincipally orientated to resolving rather than simplyidentifying any nonconformities encountered.At the same time, we make us an ideal partnerfor companies seeking the highest standards ofprofessionalism together with outstanding operatingflexibility, a combination that can make all the differenceto small and medium projects.

4

5 6

How do you knowThe only thing more important than the result is the method to obtain it.

Our services meet all needsin a comprehensive and flexible way.

ENGINEERING DESIGN

CONSTRUCTION

CONTAINMENT

VALIDATION

COMPUTER SYSTEM VALIDATION

GMP SOLUTIONS

FEASIBILITY STUDY&FACILITY PLANNING

8

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

CONSTRUCTIONMANAGEMENT

CSV Life Science serves the pharmaceutical market withengineering solutions and validation services for theLife Science sector, offering significant GxP expertise.Our track record includes leading-edge solutions forthe Secondary Pharmaceutical Industry, Medical DeviceManufacturers, Laboratories and API Companies, aswell as the Fine Chemicals and Food Industries.CSV Life Science has the experience and specialistresources to provide an integrated service covering theentire product life cycle, from the conceptualdesign and analysis of a department or wholemanufacturing site through to basic and detailengineering, qualification, validation and the resolutionof any related product release problems in accordance

with all the relevant standards.

CONSTRUCTIONLump sum turn key solutions

CSV LIFE SCIENCE supports our customers inconstruction phase, supplying plants on Lump SumTurn Key (LSTK) basis, and/or providing on site ProjectManagement and Construction Supervision services.During construction phase, a Construction Manageris present at the job site for the whole period ofconstruction and is responsible for coordination of allfield activities.

7

10

Containment

We provide the best and most cost effective solutions available

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.

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®DoverPac Continuous Liner SystemDoverPac SFDrum Transfer System DTSFlexible Glove-BoxesMilling under protectionFlexible clean roomAseptic / Steril flexible isolatorsTurn Key Containment SolutionSMEPAC TestPowoder Flexible wnading System

9

12

GMP SOLUTIONSEverything in its placefor perfect conclusion

11

Compliance area boast of competence in production systems and equipment

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:

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

Data Sheet

Services&Case Histories

CSV LIFE SCIENCE

Via Selvanesco 75 20142 MILANO Italia info@csv-ls.com www.csv-ls.comPhone 02 274393.1 Fax 02 274393200