Engineering Services From Conceptual Design Till Validation



CSV operates in the fields of Validation and Pharmaceutical Engineering and Construction.
Over the years, CSV Life Science, has built upon the leading expertise of the engineering professionals who founded and drive the company to provide leading-edge Design, Construction, Validation, Compliance and Computer System Validation services that are closely tailored to the needs of our customers, both large and small alike.



ITALY



ENGINEERING DESIGN





CSV supplies engineering solutions starting from preliminary and strategic feasibility studies, on new or existing chemical, pharmaceutical sites, up to basic and detailed engineering services, providing a global project vision.



Construction





CSV 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 coordinating of all field activities.

CONSTRUCTION MANAGEMENT

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

• COORDINATION OF CONSTRUCTION ACTIVITIES

• SAFETY COORDINATION

• SCHEDULING AND COST CONTROL

• CONTRACT DEFINITION AND MANGEMENT

• COMMISSIONING AND VALIDATION INTEGRATION



Validation & Compliance





•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 Issuess

• Quality system outline

• Policy outline

• Computer system validation

•VMP and VP of computerized systems

• User requirements outline and project documents reviews

• Suppliers audit

• 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



Containment





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 customized solutions in the pharmaceutical field, such as:

Powder Containment (validated 10-9 g) classified from OEB1 (>1000 µg/m³) to OEB5 (<1 µg/m³).

Smart flexible solutions Introduction of containment systems suitable for an existing plant.



API & Intermediate Sourcing





API and Fine Chemicals Sourcing for Pharmaceutical market.

A Company focused on being a qualified worldwide partner with high competence in finding Fine Chemical Intermediates and API (Active Pharmaceutical Ingredients) for Chemical and Pharmaceutical market.

CSV Active, established in 2013, is the most recent company of the Group: it was born to complete the wide spectrum of CSV Life Science services, focused on being a qualified worldwide partner with high competence in Fine Chemical Intermediates and API (Active Pharmaceutical Ingredients) trading.

CSV Active is a young company itself, but skilled people working long since in intermediates and API trading core business are linked to an high efficient suppliers network qualified in technical-regulatory requirements fulfillment.

Our goal is to introduce to the pharmaceutical market a dynamic and highly knowledgeable company as a fully transparent intermediary between suppliers and customers.

CSV Active also believe that confidentiality and reserve are key players in a successful business.



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