PROPOSAL - Company Profile CSV

pure engineering pure passion

pure engineering pure passion

CSV Life Science

Everything is connectedin a work project:dreams, ideas, solutionsresults and people.We are the lines between.

CSV Life Science

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.

Our services meet all needsin a comprehensive and flexible way

our servicesservices

Faisability Studyand Facility Planning

Engineerign design

Construction

Containment

GMP Solutions

Validation

Computer System Validation

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

LuMP SuM turn kEy SOLutIOnSCSV 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.

constructionconstructionmanagement

During the process construction activities, CSV Life Science provides the following services

Coordination of construction actvities

Safetycoordination

Schedulingand cost control

Commisioning and validation integration

Schedulingand cost control

Contract definitionand management

Validation is a requirement,our expertise is a tradition,your confidence is the natural result

computer system validationvalidation

We are able to provide the following services in accordance with the current regulations and guidelines for the sector (GAMP, PIC/S Guidance, FDA 21 CFr Part 11, etc.):

Quality system outline

Suppliers audit

VMP and VP of computerized systems

Computer system validation

Policy outline

User requirements outline and project document reviews

Risk analysis-based approach

Support to development and testing

Gap analysis of existing systems and corrective action plans

Validation and validation report

Administrative SOPs definition

Training on rules and guidelines

feasibility studyOptimization is in our DNA

Our Engineering support includes dedicated Facility Planning services.these services consist in the provision of layout analysis and design support as the preliminary, often strategic phase in the process of developing and/or restructuring industrial sites (whether individual departments or entire manufacturing sites).the approach followed starts with the strategic design of a Site Master Plan that optimises the flows of materials, people and equipment in our client’s manufacturing processes in order to then specify the optimal system, technological and procedural solutions for the constraints identified.the Site Master Plan does not concern itself solely with technical considerations, but also takes financial, research and development, purchasing, production transfer and marketing requirements into account, proposing solutions that our client company’s directors or owners can immediately recognise as offering financial and technical benefits.A distinctive feature of our services is that they also focus on the analysis and design of materials handling and storage systems and equipment to support these processes, as well as energy saving study.

facility planning

services&case histories

datasheet

Via Selvanesco 75 20142 MILANO Italia [email protected] www.csv-ls.comPhone 02 274393.1 Fax 02 274393200